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Hem-O-Lok Ligation Clip

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062914

by Teleflex Medical

Identifiers

510(k) Number
K062914 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 Hem-O-Lok Ligation Clip is a Clip, Implantable designed for vascular and tissue ligation. It employs a locking mechanism to securely occlude blood vessels and prevent bleeding during surgical procedures, ensuring reliable closure without the need for sutures or ties.

This device is intended for single-use in both open and laparoscopic surgical settings. Supplied sterile, it is classified as Class II under FDA regulations (878.4300) and holds a 510(k) clearance for substantial equivalence. Multiple registration numbers and FEI numbers are associated with its distribution, reflecting its broad application in general and plastic surgery. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

What surgical settings is the Hem-O-Lok Ligation Clip designed for, and how is it intended to be used during procedures?

The Hem-O-Lok Ligation Clip is designed for use in both open and laparoscopic surgical settings. It is intended to securely occlude blood vessels and prevent bleeding during surgery by employing a locking mechanism, eliminating the need for sutures or ties. This makes it particularly useful in procedures where reliable vascular or tissue ligation is required.

Is the Hem-O-Lok Ligation Clip meant for single-use or repeated use, and how should it be handled to maintain sterility?

The Hem-O-Lok Ligation Clip is explicitly intended for single-use only. Since it is supplied sterile, proper sterile medical device protocols must be followed during storage and handling to ensure its integrity before use. Reuse is not recommended or supported by the manufacturer.

What types of surgical specialties commonly utilize the Hem-O-Lok Ligation Clip, and how does this relate to its regulatory classification?

The Hem-O-Lok Ligation Clip is primarily used in general and plastic surgery, as indicated by its regulatory submissions and advisory committee categorization. Its classification as a Class II device under FDA regulations (product code FZP) reflects its role in specialized surgical procedures where vascular or tissue ligation is critical, ensuring it meets stringent performance standards for these applications.

Are there different sizes or models of the Hem-O-Lok Ligation Clip, and if so, how would a clinician determine the appropriate one for a procedure?

While the provided data does not specify exact sizes or model variations, the Hem-O-Lok Ligation Clip is designed to accommodate various vascular and tissue ligation needs. Clinicians should refer to the manufacturer’s documentation or surgical guidelines to select the appropriate size based on the vessel or tissue diameter and procedural requirements. Teleflex Medical’s product literature typically outlines compatibility for different anatomical applications.

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: Weck® Polymer Ligation | US | Teleflex, Weck® Hem-o-lok® Polymer Ligation Clips | Polymer Clips | Ligation ..., PDF Hem-o-lok - Teleflex, Teleflex Incorporated - Weck Surgical Catalog

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Teleflex Medical

Sources (1)

  • FDA 510(k) K062914 24 fields · synced Sep 19, 2026