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Endo Clip III 5MM Clip Applier

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121194

by Covidien

Identifiers

510(k) Number
K121194 FDA 510(k)
FDA Product Code
FZP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4300 FDA 510(k)
Regulation Number
878.4300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Endo Clip III 5mm Clip Applier is a laparoscopic device designed for securing tissue during minimally invasive surgical procedures. It applies titanium clips to ligate vessels or ducts, reducing the risk of bleeding or leakage. This device falls under the classification of a clip, implantable, and is intended for use in general and plastic surgery applications.

The device is supplied as a single-use, non-sterile item, requiring sterilization prior to use. It is compatible with 5mm trocars and can be adapted for use with larger trocars via a converter. The applier includes 18 titanium clips and features a shaft length of approximately 33 cm. It holds an FDA 510(k) clearance under the Special 510(k) review pathway, with the classification code FZP and regulation number 878.4300.

Frequently asked questions

What is the Endo Clip III 5mm Clip Applier used for?

The Endo Clip III 5mm Clip Applier is designed for laparoscopic surgery to secure tissue by applying titanium clips. This helps ligate vessels or ducts, minimizing the risk of bleeding or leakage during procedures in general and plastic surgery.

How is the Endo Clip III 5mm Clip Applier supplied and prepared for use?

The device is supplied as a single-use, non-sterile item. It must be sterilized prior to use to ensure safety and efficacy in the operating room. This ensures compliance with surgical standards before application.

Is the Endo Clip III 5mm Clip Applier reusable or single-use?

The Endo Clip III 5mm Clip Applier is explicitly designed for single-use only. This design choice aligns with best practices for minimizing infection risks and maintaining device integrity during surgical procedures.

What are the key specifications of the Endo Clip III 5mm Clip Applier?

The device features a shaft length of approximately 33 centimeters and includes 18 titanium clips. It is compatible with 5mm trocars and can be adapted for use with larger trocars via a converter, offering flexibility in surgical setups.

How should the Endo Clip III 5mm Clip Applier be stored?

Since the device is non-sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the device remains in optimal condition until sterilization and use.

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: Endo Clip™ clip applier - Medtronic, Covidien 176630 - Endo Clip III Clip Applier 5mm - 6/Box - Order at the ..., Laparoscopic clip applier 5 mm | Endo Clip™ III Covidien

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA 510(k) K121194 24 fields · synced Oct 1, 2026