Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed Stapler
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102632 FDA 510(k)
- FDA Product Code
- GDW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4750 FDA 510(k)
- Regulation Number
- 878.4750 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ethicon Endo-Surgery 5mm Laparoscopic Multi-Feed Stapler is a medical device used for approximation of tissue in minimally invasive procedures. It is a laparoscopic stapler designed for use in various surgical applications.
The device is supplied as a single-use instrument and is intended for use in a variety of surgical settings. It has received FDA 510(k) clearance and is classified as a Class 2 device with the regulation number 878.4750. The device is 5mm in size and is designed for use in laparoscopic procedures.
Frequently asked questions
What is the intended use of the Ethicon 5mm Laparoscopic Stapler?
The device is intended for approximation of tissue in minimally invasive procedures, such as laparoscopic surgeries.
Is the Ethicon 5mm Laparoscopic Stapler reusable?
No, the device is supplied as a single-use instrument.
What is the size of the Ethicon 5mm Laparoscopic Stapler?
The device is 5mm in size, designed for use in laparoscopic procedures.
What regulatory clearance has the Ethicon 5mm Laparoscopic Stapler received?
The device has received FDA 510(k) clearance and is classified as a Class 2 device with regulation number 878.4750.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ethicon Endo-surgery 5mm Laparoscopic Multi-feed Stapler (K102632 ..., Ethicon Endo-surgery 5mm Laparoscopic Multi-feed Stapler, Ethicon Endo-surgery 5mm Laparoscopic Multi-feed Stapler, ETHICON™ 4000 Stapler System | J&J MedTech US, LIGAMAX™ 5 Endoscopic Multiple Clip Applier | J&J MedTech US
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102632 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA 510(k) K102632 24 fields · synced Sep 28, 2026