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Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligt…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132658

by Teleflex Medical

Identifiers

510(k) Number
K132658 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 Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, and Horizon Ligating Clips are metal ligating clips used for closure in surgical procedures. These clips are designed to provide secure ligation during various surgical applications.

The Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, and Horizon Ligating Clips are supplied in various sizes and are intended for single-use. They are manufactured by Teleflex Medical and have received FDA 510(k) clearance with the product code FZP.

Frequently asked questions

What are Hemoclip Ligating Clips used for in surgical procedures?

Hemoclip Ligating Clips are metal clips designed to provide secure ligation during various surgical applications. They are used for closure in surgical procedures to ensure proper sealing of blood vessels or tissues.

What sizes are available for Hemoclip Ligating Clips?

The Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, and Horizon Ligating Clips are supplied in various sizes to accommodate different surgical needs and anatomical structures.

Are Hemoclip Ligating Clips single-use or reusable?

Hemoclip Ligating Clips are intended for single-use only. They should not be reused or resterilized as this could compromise their integrity and effectiveness in providing secure ligation.

What is the regulatory status of Hemoclip Ligating Clips?

Hemoclip Ligating Clips have received FDA 510(k) clearance with the product code FZP. They are classified as Class II medical devices and are manufactured by Teleflex Medical.

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: Teleflex Incorporated - Weck Surgical Catalog, Teleflex Incorporated - Weck Surgical Catalog, PDF weck ligation solutions - Teleflex, Weck® Hemoclip® Traditional Tantalum Metal Ligation Clips | Metal Clips ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Teleflex Medical

Sources (1)

  • FDA 510(k) K132658 24 fields · synced Sep 27, 2026