HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 17, 2026 Ethicon Endo-Surgery, LLC Hillary Lewis Senior Regulatory Affairs Specialist 475 Calle C Guaynabo, PR 00096-9 Re: K254196 Trade/Device Name: HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, HGI, LFL Dated: August 19, 2026 Received: August 19, 2026 Dear Hillary Lewis: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254196 - Hillary Lewis Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K254196 - Hillary Lewis Page 3 Sincerely, # Colin K. Chen -S Digitally signed by Colin K. Chen -S Date: 2026.09.17 21:16:15 -04'00' Colin Kejing Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254196 | ? | | Please provide the device trade name(s). | | ? | | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | | | | Please provide your Indications for Use below. | | ? | | The HARMONIC™ 1100 Shears instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic, thoracic, "otorhinolaryngology (ENT)" and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels, up to and including 7 mm in diameter, using the Energy Button with Advanced Hemostasis. "The HARMONIC™ 1100 Shears device is indicated for otorhinolaryngology (ENT) procedures in pediatric and adult patients for the ligation and division of vessels, lymphatics and tissue bundles, 2.3-3 mm away from unintended thermally sensitive structures." | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} Johnson&Johnson MedTech Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, Puerto Rico 00969, USA Surgery K254196 # 510(k) Summary # I. Submitter Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 Contact: Hillary Lewis Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. Email: hlewis6@its.jnj.com (513) 337-7000 Date Prepared: 16 September 2026 # II. Subject Device | Trade Names: | Product Codes: | | --- | --- | | HARMONIC™ 1100 Shears, 20cm | HAR1120 | | HARMONIC™ 1100 Shears, 36cm | HAR1136 | | Classification Name: | Electrosurgical, Cutting, Coagulation, & Accessories | | --- | --- | | Classification Regulation: | 21 CFR 878.440 | | Device Class: | II | | Product Code: | GEI | | Subsequent Product Codes: | HGI, LFL | # III. Predicate Device | Predicate Device 510(k) Number | Predicate Device Name | Predicate Device Product Codes | | --- | --- | --- | | K200841 | HARMONIC™ HAR1120 Shears, 20cm length; HARMONIC™ HAR1136 Shears, 36cm length | HAR1120, HAR1136 | 510(k) Premarket Notification (Traditional): K254196 1 {5} K254196 # IV. Reference Devices | Trade Name | | Model Number | 510(k) Holder | | --- | --- | --- | --- | | Reference Devices | HARMONIC ACE+ with Adaptive Tissue Technology | HAR23 HAR36 | Ethicon Endo-Surgery, LLC K120729 K121550 | | | HARMONIC ACE+7 with Advanced Hemostasis | HARH23 HARH36 HARH45 | Ethicon Endo-Surgery, LLC K132612 | | | HARMONIC 700 with Advanced Hemostasis | HAR723 HAR736 HAR745 | Ethicon Endo-Surgery, LLC K221790 | | | HARMONIC HD 1000i | HARHD20 HARHD36 | Ethicon Endo-Surgery, LLC K160752 K191555 | | | HARMONIC™ ACE Curved Shears with Scissor and Ergonomic Handle | ACE14S ACE23E ACE36E | Ethicon Endo-Surgery, LLC K051036 K132512 | | | HARMONIC™ ACE Curved Shear with Ergonomic Handle | ACE45E | Ethicon Endo-Surgery, LLC K051036 K132522 | | | UltraCision™ HARMONIC Scalpel™ LCS and CS Curved Shears | CS14C CS23C LCSC5 | Ethicon Endo-Surgery, LLC K002981 K993054 | | | HARMONIC™ WAVE Coagulating Shears with Scissor Handle and Hand Control | WAVE18S | Ethicon Endo-Surgery, LLC K062000 | 510(k) Premarket Notification (Traditional): K254196 2 {6} K254196 ## V. Device Description The HARMONIC™ 1100 Shears instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The HARMONIC™ 1100 Shears instrument is a sterile, single-patient-use instrument used for dissection, grasping, coagulation, and cutting of soft tissue between the blade and clamp arm. It consists of an ergonomic handle with an integrated hand piece and two energy delivery buttons. Energy Button – The user can adjust power levels from 1 through 5. Energy Button with Advanced Hemostasis – Is meant for large vessel sealing; user cannot adjust. The instrument is available in two shaft lengths – 20cm and 36cm. An integrated audible and tactile mechanism in the handle indicates full trigger closure. The instrument has a clamp arm and curved blade that are designed to work through a 5mm trocar, through a 5mm reducer cap in a large diameter trocar, or through an incision without the use of a trocar. The two dashes on the handle of the instrument are intended to represent relative vessel size. The Energy Button is indicated for vessels up to 5mm in diameter. When the Energy Button is used, cutting speed is the fastest. The Energy Button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7mm in diameter. When the Energy Button with Advanced Hemostasis is used, cutting speed is reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology that is specific to the HARMONIC™ 1100 Shears. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. The HARMONIC™ 1100 Shears instrument is compatible with Ethicon Endo-Surgery Generator G11 (GEN11), software version 2018_1 or later, or other compatible Ethicon Generators. Refer to the Ethicon Generator Operator’s Manual for more information. This device is intended to be used by healthcare professionals trained and experienced in open and endoscopic surgery involving soft tissue incisions and in the use of ultrasonic devices. 510(k) Premarket Notification (Traditional): K254196 3 {7} K254196 ## VI. Intended Use/Indications for Use This submission is to expand the indications for use to include *otorhinolaryngology (ENT)*. The HARMONIC™ 1100 Shears instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic, thoracic, *otorhinolaryngology (ENT)* and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels, up to and including 7 mm in diameter, using the Energy Button with Advanced Hemostasis. *The HARMONIC™1100 Shears device is indicated for otorhinolaryngology (ENT) procedures in pediatric and adult patients for the ligation and division of vessels, lymphatics and tissue bundles, 2.3-3 mm away from unintended thermally sensitive structures.* The HARMONIC™ 1100 Shears instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Subject, predicate and all reference/legacy devices: - Have the same intended use. - Are ultrasonic surgical instruments intended to cut and control bleeding from soft tissues and vessels during open and endoscopic procedures. - Are intended for use as an adjunct to or substitute for electrosurgery, lasers or manual scalpels in several different clinical specialties, for sealing and transecting vessels, and for dissection. - Are surgical tools used by surgeons during open and endoscopic procedures that share the same function to simultaneously cut and cauterize tissue and vessels using ultrasonic vibration. - Have the same tissue/body contact and limited duration of use from a biocompatibility perspective. Additionally, the subject device, predicate device, HARMONIC ACE+7, HARMONIC 700, and HARMONIC HD1000i devices: - Coagulate vessels up to and including 7 mm in diameter with the Energy Button with Advanced Hemostasis. 510(k) Premarket Notification (Traditional): K254196 4 {8} K254196 ### VII. Technological Comparison No design or specification changes are associated with the expanded indication of the HARMONIC 1100 Shears. The fundamental technological characteristics: - Device design - Patient-contacting materials - Chemical composition - Energy source - Mechanism of action of the HARMONIC 1100 Shears are equivalent to the predicate and reference devices. Additionally, prior performance rationales and testing in premarket submission, K200841 and K160752 provide equivalency support in: - Testing in accordance with IEC 60601-1-2, IEC 60601-1 - Biocompatibility (ISO 10993-1) - Bench Testing including sealed vessel burst pressure test, grasping force, and tissue pad removal force. The subject device will have an expanded indication for use into the otorhinolaryngology (ENT) space. ### VIII. Non-Clinical and/or Clinical Studies In support of the expanded indication, acute preclinical histology reports and stratified histological thermal spread from all reference, predicate, and subject devices were provided. The performance data presented in the stratified histological thermal spread data demonstrates the subject device equivalence to all reference and predicate devices. ### Clinical Studies In support of the expanded indication a single-arm, retrospective, descriptive, observational cohort study was performed utilizing the Premier Healthcare Database, one of the most comprehensive large multi-institutional electronic healthcare databases in the United States. ### Retrospective Cohort Study Purpose: The retrospective cohort study was designed to provide clinical evidence using real-world data from routine clinical care on outcomes of interest among a nationally 510(k) Premarket Notification (Traditional): K254196 5 {9} K254196 representative sample of patients undergoing otorhinolaryngologic (ENT) procedures using HARMONIC Shafted Shears, including - HARMONIC™ 1100 Shears - HARMONIC™ HD 1000i Shears - HARMONIC™ 700 Shears - HARMONIC ACE™+7 Shears with Advanced Hemostasis - HARMONIC ACE™+ Shears with Adaptive Tissue Technology - Harmonic Ace Curved Shears with Ergonomic Handle Hand Control and Torque Wrench - Harmonic Ace Curved Shears with Scissor Handle and Hand Control - Harmonic Wave™ Coagulating Shears with Scissor Handle and Hand Control - UltraCision™ Harmonic Scalpel® LCS and CS Curved Shears. Methods: Patients who underwent ENT procedures using the above HARMONIC Shafted Shears were identified, with the index procedure defined as the first qualifying procedure within the first healthcare encounter, meeting these criteria during the study period in the Premier Healthcare Database. Patients with a healthcare facility not contributing data for at least 180 days prior to and 30 days post-index procedure or with a route of admission from another facility at index were excluded. Descriptive analyses were used to characterize patient, procedural, hospital, and provider characteristics at the time of the index procedure. The cumulative incidences of the following outcomes of interest were measured using descriptive analyses within 30 days after the index procedure: overall complications - transient laryngeal nerve injury (thyroidectomy and parathyroidectomy procedures only) - hypocalcemia (thyroidectomy and parathyroidectomy procedures only) - facial nerve injury (parotidectomy procedures only - bleeding-related complications (a composite outcome including major and non-major bleeding); and - infection (a composite outcome including sepsis and surgical site infection). The cumulative incidence of hospital readmission within 30 days after discharge from the index healthcare encounter and the mean hospital length of stay at index were also measured. For binary outcomes, cumulative incidences were measured as proportions, and 95% confidence intervals (CIs) were calculated for each outcome of interest using the Clopper-Pearson exact method. All analyses among patients undergoing ENT procedures using HARMONIC Shafted Shears were conducted by procedure types. Subgroup analyses among patients using HARMONIC® 1100 Shears 510(k) Premarket Notification (Traditional): K254196 6 {10} K254196 or HARMONIC® HD 1000i Shears focused on thyroidectomy, parathyroidectomy, and neck dissection because the sample size was small for other ENT procedures. Given the technological equivalencies, clinical evidence provided from the full family of HARMONIC Shears from reference device to present was appropriately compared based on each device's similarities and mode of action. Overall, the observed complication profile did not indicate a new or unexpected safety concern attributable to use of the HARMONIC Shears devices in the otorhinolaryngology (ENT) space. Results: Patients undergoing ENT procedures with HARMONIC Shafted Shears were generally 52–61 years of age, except for those undergoing tonsillectomy and/or adenoidectomy, who had a mean age of 45 years and 20.6% of patients ≤21 years old (i.e., pediatric patients). Comorbid conditions were common and varied by procedure types. Approximately 75%–95% of patients undergoing neck dissection, glossectomy, laryngectomy, or pharyngectomy and 45%–55% of those undergoing thyroidectomy, parathyroidectomy, sialoadenectomy, parotidectomy, excision of neck mass, or tonsillectomy and/or adenoidectomy had at least two comorbid conditions. Concurrent ENT procedures varied by procedure types and were most common with neck dissection, glossectomy, laryngectomy, pharyngectomy, tonsillectomy and/or adenoidectomy. The available real-world clinical evidence observed 30-day cumulative incidences of complications and hospital readmission were low or within the ranges reported in the prior literature. Transient laryngeal nerve injury was rare among patients undergoing thyroidectomy or parathyroidectomy. There were zero facial nerve injury events among patients undergoing parotidectomy. The results from this large single-arm, retrospective, descriptive, observational cohort study, conducted using a large nationally representative healthcare database in the United States, supports the safe use of HARMONIC Shafted Shears in otorhinolaryngology (ENT) procedures. # IX. Literature Review A systematic literature review was executed in support of the current indication expansion submission. The scope of the systematic literature review was to provide use cases on otorhinolaryngology (ENT) procedures utilizing the HARMONIC Shafted 510(k) Premarket Notification (Traditional): K254196 7 {11} K254196 Shears devices, from reference to subject. The systematic literature review included research from three core scientific databases, Embase and Medline via OVID and PubMed. The study design focused on the inclusion of in-process and other non-indexed citations, Epub ahead of print, and daily updates. Search parameters included all full text articles from all the databases searched and results were reported to ReadCube Papers. After automatic deduplication, the final full text and metadata were additionally searched specifically for the Subject Trade Device Names. The relevant articles were further stratified from the total. Relevant articles included in this submission were from all three databases, including both preclinical and clinical studies. # X. Conclusion Ethicon Endo-Surgery, LLC evaluated real-world data from the Premier Healthcare Database. The real-world evidence synthesized from the report and subsequent peer-reviewed literature indicate ultrasonic laparoscopic dissectors have current successful use in otorhinolaryngology (ENT) cases consistent with the current standard of care. The non-clinical data provided encompassing the reference, predicate, and subject devices, in addition to the systemic literature review and retrospective clinical analysis support the safety of the HARMONIC 1100 Shears devices for the otorhinolaryngology (ENT) surgical procedures indicated. As all testing and cumulative criteria demonstrate that ultrasonic laparoscopic dissectors perform as intended within the current standard of care. We can conclude that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness for the requested indications for use. 510(k) Premarket Notification (Traditional): K254196 8