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Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and Appliers

by Kirwan Surgical Products, Inc.

510(k) K060915

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060915 Date17 Apr 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HCH
Device Class
Class II
Regulation
21 CFR Part 882.5200
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device consists of metallic aneurysm clips and corresponding appliers used in neurosurgical procedures. The Kirwan L-aneurysm clips and Yasargil-type aneurysm clips are designed for the temporary or permanent occlusion of intracranial aneurysms.

The device is intended for use in an operating room setting by neurosurgeons. It is supplied as a reusable instrument system and has received FDA 510(k) clearance under K060915, classified as a Class II device under regulation 882.5200 for aneurysm clips and 882.4175 for appliers.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Kirwan L-aneurysm clip and Yasargil-type clip system used for?

    The Kirwan L-aneurysm clips and Yasargil-type aneurysm clips are designed for the temporary or permanent occlusion of intracranial aneurysms during neurosurgical procedures, used by neurosurgeons in an operating room setting to control blood flow to the aneurysm.

  • Is the Kirwan aneurysm clip and applier system reusable or single-use?

    The device is supplied as a reusable instrument system, meaning the metallic aneurysm clips and corresponding appliers are intended for multiple uses after proper cleaning and sterilization between procedures, as indicated in the device description.

  • What regulatory clearance does the Kirwan aneurysm clip and applier system have?

    The device has received FDA 510(k) clearance under submission number K060915, which confirms it is substantially equivalent to a legally marketed predicate device, and is classified as a Class II device under regulations 882.5200 for clips and 882.4175 for appliers.