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Amsel Occluder Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172479

by Amsel Medical

Identifiers

510(k) Number
K172479 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 Amsel Occluder Device is a mechanical occlusion implant intended for use in open general surgery procedures on tubular structures or vessels where a metal ligating clip is indicated. It is designed to occlude vessels within a diameter range of 2.0 mm to 7.0 mm. The device is classified as a Class 2 implantable clip under product code FZP and is cleared through the Special 510(k) pathway.

The device is supplied as a single-use, sterile implant and is intended for open surgical settings. It is manufactured by Amsel Medical and authorized under FDA 510(k) clearance with decision number SESE. Storage conditions and specific handling instructions are not detailed in the available data, and no MRI safety information is provided.

Frequently asked questions

What is the Amsel Occluder Device used for?

The Amsel Occluder Device is a mechanical occlusion implant designed for use in open general surgery procedures on tubular structures or vessels where a metal ligating clip is indicated. It is specifically intended to occlude vessels within a diameter range of 2.0 mm to 7.0 mm.

How is the Amsel Occluder Device supplied?

The device is supplied as a single-use, sterile implant intended for open surgical settings. It is manufactured by Amsel Medical and is classified as a Class 2 implantable clip under product code FZP. Specific storage conditions and handling instructions are not detailed in the available data.

What is the regulatory status of the Amsel Occluder Device?

The Amsel Occluder Device is authorized under FDA 510(k) clearance with decision number SESE and is classified as a Class 2 implantable clip. It is cleared through the Special 510(k) pathway and was reviewed by the General, Plastic Surgery advisory committee.

Is the Amsel Occluder Device reusable or MRI safe?

The Amsel Occluder Device is supplied as a single-use implant, meaning it is not intended to be reused. No MRI safety information is provided in the available data for this device.

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: Amsel Medical Corporation, AMSEL OCCLUDER DEVICE (K140932) — FDA 510 (k) | Innolitics, K172479 FDA 510 (k) - Amsel Occluder Device | Amsel Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Amsel Medical

Sources (1)

  • FDA 510(k) K172479 24 fields · synced Sep 23, 2026