LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 15, 2026 Covidien, LLC Marissa Miller Senior Regulatory Affairs Specialist Contact Address Re: K261070 Trade/Device Name: LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, SCV Dated: August 6, 2026 Received: August 7, 2026 Dear Marissa Miller: 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. {1} K261070 - Marissa Miller Page 2 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" (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- {2} K261070 - Marissa Miller Page 3 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). Sincerely, MARK Digitally signed by MARK TRUMBORE -S TRUMBORE -S Date: 2026.09.15 11:36:56 -04'00' Mark Trumbore, 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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K261070 Device Name LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated Indications for Use (Describe) The LigaSure™ Robotically Assisted Surgery (RAS) Maryland Jaw Vessel Sealer/Divider is a bipolar electrosurgical instrument intended for use with the Hugo™ RAS System where ligation, and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use with the Hugo™ RAS System during the representative surgical procedures set forth in the Hugo™ RAS System Indications Document and the Hugo™ RAS System User's Guide Instrument Addendum. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider for these procedures. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} # K261070 510(k) Summary (21 CFR 807.92) Date: September 14, 2026 510(k) Submitter Covidien llc 200 Medtronic Dr. Lafayette, CO 80026 Contact Marissa Miller, Sr Regulatory Affairs Specialist Telephone: 601-790-9820 Email: Marissa.miller@medtronic.com Subject Device Trade Name: LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider Sealing, Nano-coated Common Name: Bipolar Vessel Sealing Device Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400) Regulatory Class: II Product Code: GEI Associated Product Code: SCV Predicate Device Trade Name: LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated Common Name: Bipolar Vessel Sealing Device Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400) Regulatory Class: II Product Code: GEI 510(k): K170869 (cleared: April 21, 2017) Manufacturer: Covidien llc Reference Device Trade Name: Hugo™ RAS Bipolar Maryland Forceps (cleared under Hugo Robotically Assisted Surgery (RAS) System) Common Name: System, surgical, computer-controlled instrument Classification Name: Modular Electromechanical Surgical System (21 CFR 878.4964) Regulatory Class: II Product Code: SCV 510(k): K250725 (cleared: December 03, 2025) Manufacturer: Covidien llc Page 1 {5} ## Device Description The LigaSure™ Robotically Assisted Surgery (RAS) Maryland Jaw Vessel Sealer/Divider device is a sterile, single-use, minimally invasive, radiofrequency (RF) advanced bipolar vessel sealer/divider, designed for use with the Hugo™ RAS System and powered by an electrical surgical unit (ESU), the Valleylab™ FT10 Energy Platform. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, henceforth referred to as the LigaSure™ RAS Maryland device, is designed to perform blunt dissection, vessel sealing (ligation), and division (cutting) of vessels, thick tissue bundles, and lymphatic tissue. All instrument movements are controlled by the surgeon via the surgeon console on the Hugo™ RAS System. ## Indications for Use The LigaSure™ Robotically Assisted Surgery (RAS) Maryland Jaw Vessel Sealer/Divider is a bipolar electrosurgical instrument intended for use with the Hugo™ RAS System where ligation, and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use with the Hugo™ RAS System during the representative surgical procedures set forth in the Hugo™ RAS System Indications Document and the Hugo™ RAS System User's Guide Instrument Addendum. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider for these procedures. ## Comparison of Technological Characteristics with the Predicate The LigaSure™ RAS Maryland device is equivalent to the predicate device (LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, henceforth referred to as LigaSure™ Maryland device) in terms of in terms of intended use, fundamental performance and distal-end design (jaw and shaft), electrosurgical unit (ESU) connector, materials, energy type, sterilization, packaging, shelf life, and risk profile.. While the distal portion of the subject device is equivalent to the predicate device, the proximal end has been modified to enable compatibility with the Hugo™ robotic-assisted surgery (RAS) System. A reference device is necessary and appropriate to support verification and validation methods of the proximal end of the subject device. The reference device is utilized exclusively to demonstrate the functionality of the proximal interface with the robotic system. The intended use and performance characteristics remain equivalent to those of the predicate device, and the proximal modifications for Hugo™ RAS System compatibility do not adversely affect the subject device's safety or effectiveness. In conclusion, the differences between the predicate and subject device are not critical to the intended surgical use of the device, and do not affect the safety and effectiveness of the device when used as labeled. Page 2 {6} Table 1: Substantial Equivalence Comparison Table | Characteristic | Predicate Device LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing (K170869) | Subject Device LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider | Comparison | | --- | --- | --- | --- | | Intended Use | The intended purpose of the devices is to ligate and divide vessels, tissue bundles, and lymphatics. | The intended purpose of the devices is to ligate and divide vessels, tissue bundles, and lymphatics. | Same | | Indications for Use | The LigaSure™ Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure™ Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure™ system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure™ system for these procedures. | The LigaSure™ Robotically Assisted Surgery (RAS) Maryland Jaw Vessel Sealer/Divider is a bipolar electrosurgical instrument intended for use with the Hugo™ RAS System where ligation, and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use with the Hugo™ RAS System during the representative surgical procedures set forth in the Hugo™ RAS System Indications Document and the Hugo™ RAS System User's Guide Instrument Addendum. The LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider for these procedures. | Different Both devices have the same intended use however the indications for LigaSure™ RAS Maryland are limited to the indications for the Hugo™ RAS System. The reduced scope of procedure indications compared to the predicate does not affect the safety and effectiveness of the subject device. | | Contraindications | None | None | Same | | Maximum Vessel Diameter | 7 millimeters (mm) | 7 mm | Same | | Single Use | Yes | Yes | Same | | Sterile | Yes | Yes | Same | | Sterilization Method | EO | EO | Same | | Electrical Characteristics | | | | | Energy Type | Electrical (RF) bipolar energy | Electrical (RF) bipolar energy | Same | Page 3 {7} | Characteristic | Predicate Device LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing (K170869) | Subject Device LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider | Comparison | | --- | --- | --- | --- | | **Mechanical Characteristics** | | | | | **Proximal end Design** | Handheld Pistol Grip | RAS Compatible | **Different** The subject device is designed to be used with the Hugo RAS system. This difference is covered by the reference device. | | **Jaw Characteristics** | | | | | **Functional Materials** | | | | | **Jaw Seal Plate** | Stainless Steel | Stainless Steel | **Same** | | **Jaw Insert** | Stainless Steel | Stainless Steel | **Same** | | **Jaw Gap Spacer** | Encapsulant Paste | Encapsulant Paste | **Same** | | **Jaw Insulation Material** | Polypththalamide (PPA) | Polypththalamide (PPA) | **Same** | | **Blade Material** | Stainless Steel | Stainless Steel | **Same** | | **Outer Tube Material** | Stainless Steel | Stainless Steel | **Same** | | **Jaw Coating Material** | Hexamethyldisiloxane | Hexamethyldisiloxane | **Same** | | **Patient Contacting Materials Biocompatible per ISO 10993-1** | Yes | Yes | **Same** | ## Verification and Validation Data Sterilization and shelf-life testing of the subject device confirmed that residual levels remained below allowable limits while maintaining the required sterilization assurance level, in accordance with applicable validation standards ISO 11135, ISO 11737-1 and ISO 10993-7. Additionally, the packaging and product integrity of the subject device were found to be acceptable for a five-year shelf life, in accordance with the applicable standards ISO 11607-1, ISO 11607-2, ASTM D4169 and ASTM F1980. Page 4 {8} Biocompatibility requirements of ISO 10993-1 were met by the subject device. The following endpoints were evaluated to ensure the device is biocompatible: - Cytotoxicity - Sensitization - Irritation - Acute Systemic Toxicity - Material Mediated Pyrogenicity - Physical/Chemical Information - Genotoxicity - Systemic toxicity - Carcinogenicity - Reproductive/Developmental Toxicity Electromagnetic compatibility (EMC), electrical and mechanical safety, as well as thermal safety testing was conducted. This testing showed the subject device, and compatible system, demonstrates conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, IEC TS 60601-4-2, and IEC 80601-2-77. Performance data included bench, animal and human factors/usability engineering studies. These studies demonstrated that the subject device performs as intended and is substantially equivalent to the predicate device, with modifications required for robotic-assisted surgery substantiated by the reference device. - Performance bench testing met clinically relevant, predetermined device acceptance criteria (requirements) for mechanical and functional performance, visual inspection, device reliability and ex vivo tissue effects and device performance. - Performance animal studies were conducted to evaluate the short- and long-term seal quality and overall performance of the subject device using clinically relevant tissue and vessels. The studies utilized porcine models because of their anatomical and physiological similarities to humans. - Human Factors and Usability Engineering studies were performed in accordance with FDA guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Feb. 3, 2016). These studies utilized cadaver models, focused on identifying the subject device's critical tasks and ensuring the safety and effectiveness of the system with the introduction of the subject device. Documentation is provided based on FDA draft guidance Content of Human Factors Information in Medical Device Marketing Submission (December 9, 2022). ## Clinical Studies This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence. Page 5 {9} # Conclusions The intended use, technological characteristics (supported by the reference device for proximal end design characteristics) and non-clinical bench performance data demonstrate that the LigaSure™ RAS Maryland Jaw Sealer/Divider, Nano-coated is substantially equivalent to the predicate LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated cleared in K170869. The verification and validation studies support the safety of the device and demonstrate that the subject LigaSure™ RAS Maryland device performs as intended when used with the compatible robotic assisted surgery system. Page 6