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Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K150840

by Ethicon Endo-Surgery, LLC

Identifiers

510(k) Number
K150840 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 Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier is a surgical device classified as a Clip, Implantable, designed for endoscopic application. It delivers multiple clips sequentially to ligate and occlude tubular structures, such as blood vessels or fallopian tubes, during minimally invasive procedures. The device features a rotating mechanism to enhance precision and control during clip deployment.

This device is intended for single-use in sterile surgical settings, including laparoscopic and endoscopic procedures. It is supplied sterile and requires no reprocessing. The Ligaclip 10mm M/L is classified as a Class II medical device under FDA regulations (510K clearance) and adheres to the MDR framework. Its design accommodates a 10mm clip size, with compatibility for endoscopic instruments, and is intended for use in general and plastic surgery applications.

Frequently asked questions

What types of surgical procedures is the Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier designed for?

The Ligaclip 10mm M/L is specifically designed for endoscopic procedures, including laparoscopic surgeries, where it is used to ligate and occlude tubular structures like blood vessels or fallopian tubes. Its rotating mechanism enhances precision during clip deployment, making it suitable for minimally invasive general and plastic surgery applications.

Is the Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier reusable or intended for single-use?

The Ligaclip 10mm M/L is explicitly intended for single-use only in sterile surgical settings. It is supplied sterile and requires no reprocessing, ensuring compliance with best practices for infection control and device integrity.

What clip size does the Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier accommodate, and how does this affect its use?

This device is designed to deploy 10mm clips, which are suitable for ligating medium-sized tubular structures. The clip size is optimized for endoscopic applications, ensuring compatibility with laparoscopic instruments while providing controlled occlusion for procedures in general and plastic surgery.

How should the Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier be stored, and what are the key considerations?

Since the Ligaclip 10mm M/L is supplied sterile and intended for single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility and device integrity until use, adhering to manufacturer guidelines for minimally invasive surgical instruments.

What regulatory pathways has the Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier followed, and what does this mean for its use?

The Ligaclip 10mm M/L has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR) framework. This classification as a Class II device under FDA regulations indicates it has been evaluated for safety and effectiveness through a formal submission process, ensuring it meets established performance standards for endoscopic clip appliers in surgical settings.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, LLC

Sources (2)

  • FDA 510(k) K150840 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026