easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 25, 2026 Ezisurg Medical Co., Ltd. % Giselle Zhang Lead RA&QA Consultant Emergo Global Consulting, LLC 2500 Bee Cave Rd. Bldg. 1, Suite 300 Austin, Texas 78746 Re: K254291 Trade/Device Name: easyEndo™ E-Lite Single Use Powered Endoscopic Staplers easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip easyEndo™ E-Lite Single Use Cartridges Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: August 25, 2026 Received: August 25, 2026 Dear Giselle Zhang: 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. {1} K254291 - Giselle Zhang Page 2 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. Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. 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. {2} K254291 - Giselle Zhang Page 3 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). Sincerely, # TEK N. LAMICHHANE -S Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K254291 Device Name easyEndoTM E-Lite Single Use Powered Endoscopic Staplers easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved Tip easyEndoTM E-Lite Single Use Cartridges Indications for Use (Describe) easyEndoTM E-Lite Single Use Powered Endoscopic Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved Tip are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. easyEndoTM E-Lite Single Use Cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical 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 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} # 510(k) Summary (K254291) ## easyEndo™ E-Lite Single Use Powered Endoscopic Staplers and Cartridges ### 1. Submission Sponsor Ezisurg Medical Co., Ltd. No.399, Miaoqiao Rd., Pudong New District, Shanghai, P.R. China Contact Name: Hong Zhu Contact Title: RA&QA VP ### 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com, Giselle.Zhang@ul.com Contact: Giselle Zhang Title: Lead QA/RA Consultant ### 3. Date Prepared 09/23/2026 ### 4. Device Identification | Trade/Proprietary Name: | easyEndo™ E-Lite Single Use Powered Endoscopic Staplers easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip easyEndo™ E-Lite Single Use Cartridges | | --- | --- | | Classification Name: | Staple, Implantable | | Regulation Number(s): | 21 CFR 878.4750 | | Product Code(s): | GDW | | Class: | II | | Classification Panel: | General & Plastic Surgery | | Classification Name: | Stapler, Surgical | K254291, Page 1 of 7 {5} Regulation Number(s): 21 CFR 878.4800 Product Code(s): GAG Class: II Classification Panel: General & Plastic Surgery ### 5. Legally Marketed Predicate Device(s) Device name: ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads 510(k) number: K202665 Manufacturer: Ethicon Endo-Surgery, LLC Device Name: Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip 510(k) Number: K141952 Manufacturer: Ethicon Endo-Surgery, LLC ### 6. Device Description The easyEndo™ E-Lite (previously named: easyEndo™ Powered) Single Use Powered Endoscopic Staplers and Cartridges, hereafter E-Lite Staplers and Cartridges, are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The E-Lite Staplers and Cartridges are sterilized by irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line. The staplers are available in three shaft lengths of 260mm, 350mm and 440mm. The Articulation Knob can articulate the jaws to 60 degrees, 45 degrees, 30 degrees, and 15 degrees in each set direction to facilitate lateral access to the operative site. The device has two staple line lengths, 45 mm and 60 mm. The staplers are packaged with a primary lithium battery pack that must be installed prior to use. The staplers are packaged without a cartridge and must be loaded prior to use. The lock out feature is designed to prevent a used or improperly installed Cartridge from being re-fired or the Stapler from being fired without a Cartridge. ### 7. Indication for Use Statement easyEndo™ E-Lite Single Use Powered Endoscopic Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. easyEndo™ E-Lite Single Use Cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. K254291, Page 2 of 7 {6} ## 8. Substantial Equivalence Discussion The following table compares the easyEndo™ to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device shares the same intended use with the predicates for transection, resection, and/or creation of anastomoses, but the safety and effectiveness of this device have not been studied for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. Although the subject device has more limited indications for use and differs in some technological characteristics, safety and performance data demonstrates that these differences do not raise any new questions of safety or effectiveness compared to the predicate device Table 1 - Comparison of Stapler Characteristics | Item | easyEndo™ E-Lite Single Use Powered Endoscopic Staplers (Proposed device) | ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads (Primary Predicate: K202665) | Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip (Secondary Predicate: K141952) | SE Discussion | | --- | --- | --- | --- | --- | | Manufacturer | Ezisurg Medical Co., Ltd. | Ethicon Endo-Surgery, LLC | Ethicon Endo-Surgery, LLC | / | | Product Code | GDW | GDW | GDW | Same | | Classification | Class II (21 CFR 878.4750 & 21 CFR 878.4740) | Class II (21 CFR 878.4750) | Class II (21 CFR 878.4750) | Same | | Indications for Use | easyEndo™ E-Lite Single Use Powered Endoscopic Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. | ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric | The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and it's reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general gynecologic, urologic, | The subject device has a more limited indication for use than the predicate device which is acceptable. | K254291, Page 3 of 7 {7} | | | surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. | thoracic, and pediatric surgical procedures. | | | --- | --- | --- | --- | --- | | Operating Principle | Powered | Powered | Powered | Same | | Cutting Mechanism | Stapler places two, triple staggered rows of staples and simultaneously cuts and divides the tissue between the two rows. | Stapler places two, triple staggered rows of staples and simultaneously cuts and divides the tissue between the two rows. | Four staggered rows of staples, two on either side of the cut line. | Equivalent | | Jaw Structure | Linear, Curved | Linear | Curved | Equivalent | | Lock-out Feature | Yes | Yes | Yes | Same | | Main Components | Cutting Knife Anvil Jaw (with or without Curved Tip) Staple Battery Pack Shaft | Cutting Knife Anvil Jaw Staple Battery Pack Shaft | Cutting Knife Anvil Jaw (with Advanced Placement Tip) Staple Battery Pack Shaft | Equivalent | | Suture Length | 45mm, 60mm | 45mm, 60mm | 35 mm | Equivalent | | Articulation Degree | Total 120° (60° in each direction) | Total 90° (45° in each direction) | Total 100° (50° in each direction) | Equivalent | | Sterilization | Irradiation sterilization | Irradiation sterilization | Irradiation sterilization | Same | | Materials or substances contacted with patient | Anvil jaw: Stainless steel 05Cr17Ni4Cu4Nb, Stainless steel 06Cr19Ni10 (304) | Stainless steel | Stainless steel | Equivalent | K254291, Page 4 of 7 {8} | | Stainless steel 12Cr17Ni7 Curved Tip: Stainless steel 05Cr17Ni4Cu4Nb and Stainless steel 12Cr17Ni7 | | | | | --- | --- | --- | --- | --- | | | Shaft: stainless steel 06Cr19Ni10 | Stainless steel | Stainless steel | | | | Cutting knife: stainless steel 20Cr13 | Stainless steel | Stainless steel | | Table 2 - Comparison of Cartridge Characteristics | Item | easyEndo™ E-Lite Single Use Cartridges (Proposed device) | ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads (Primary Predicate: K202665) | Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and reloads (Secondary Predicate: K141952) | SE Discussion | | --- | --- | --- | --- | --- | | Manufacturer | Ezisurg Medical Co., Ltd. | Ethicon Endo-Surgery, LLC | Ethicon Endo-Surgery, LLC | / | | Product Code | GDW, GAG | GDW | GDW | Same | | Classification | Class II (21 CFR 878.4750 & 21 CFR 878.4740) | Class II (21 CFR 878.4750) | Class II (21 CFR 878.4750) | Same | | Indications for Use | easyEndo™ E-Lite Single Use Cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general and thoracic surgical procedures. | ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical | The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general gynecologic, urologic, | The subject device has a more limited indication for use than the predicate device which is acceptable. | K254291, Page 5 of 7 {9} | | | | procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. | thoracic, and pediatric surgical procedures. | | | --- | --- | --- | --- | --- | --- | | Staple height | Open staple height | 2.0 mm, 2.5 mm, 3.5 mm, 3.8 mm, 4.1 mm, 4.4 mm | 2.0 mm, 2.6 mm, 3.6 mm, 3.8 mm, 4.1 mm, 4.2 mm | 2.5 mm | Equivalent | | | Closed staple height | 0.75 mm, 1.0 mm, 1.5 mm, 1.7 mm, 2.0 mm, 2.3 mm | 0.75 mm, 1.0 mm, 1.5 mm, 1.8 mm, 2.0 mm, 2.3 mm | 1.0mm | | | Row Number of Staples | | 6 | 6 | 4 | Equivalent | | Staple Shape | | Standard “B” shaped staple | Standard “B” shaped staple | Standard “B” shaped staple | Same | | Materials or substances contacted with patient | Staples: Unalloyed Titanium (Ti Grade 2) | Staples: titanium (Ti3Al2.5V) alloy | Staples: titanium (Ti3Al2.5V) alloy | Equivalent | | | | | Cartridge jaw: Stainless steel 05Cr17Ni4Cu4Nb, | Stainless steel | | Stainless steel | | | | Cartridge: PA | Unknown | | Unknown | ### 9. Non-Clinical Performance Data To demonstrate safety and effectiveness of easyEndo™ E-Lite Single Use Powered Endoscopic Staplers and Cartridges and to show substantial equivalence to the predicate device, Ezisurg completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The easyEndo™ E-Lite Single Use Powered Endoscopic Staplers and Cartridges passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device: - Staple height and formation - Staple line strength - Staple line integrity K254291, Page 6 of 7 {10} - Leak-burst pressure testing - Clamping Force - Obstruction and lockout testing - Functional testing - Electrical safety and EMC testing in accordance with IEC 60601-1 and IEC 60601-1-2 standards - Biocompatibility of materials according to ISO 10993 standards - Sterilization, packaging, transportation and shelf-life validations. Additionally, Human Factors testing was executed in accordance with the FDA Guidance Document Applying Human Factors and Usability Engineering to Medical Devices. #### **10. Animal Study** Animal testing was conducted in alignment with good laboratory practices (GLP) per 21 CFR §58. The study is intended to evaluate the safety effectiveness and handling characteristics of easyEndo™ E-Lite in a chronic and acute animal study with the predicate devices. Animals have been divided into test and control groups and performed transection, resection, and/or the creation of anastomoses on target tissues or vasculature, according to the corresponding indications and specific tissue types. In terms of safety and performance, there was no significant difference between the test and control groups, and all evaluation indicators met the acceptance criteria. #### **11. Clinical Performance Data** No clinical data was necessary to determine the substantial equivalence of this device. #### **12. Statement of Substantial Equivalence** The easyEndo™ E-Lite Single Use Powered Endoscopic Staplers and Cartridges have the same intended use as the predicate devices and similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the easyEndo™ E-Lite Single Use Powered Endoscopic Staplers and Cartridges is as safe and effective as the predicate device. Therefore, the easyEndo™ E-Lite Single Use Powered Endoscopic Staplers and Cartridges is substantially equivalent to the predicate device. K254291, Page 7 of 7