Cleared Traditional

K922272 - YASARGIL ANEURYSM CLIPS (FDA 510(k) Clearance)

Sep 1992
Decision
124d
Days
Class 2
Risk

K922272 is an FDA 510(k) clearance for the YASARGIL ANEURYSM CLIPS. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on September 15, 1992, 124 days after receiving the submission on May 14, 1992.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.

Submission Details

510(k) Number K922272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1992
Decision Date September 15, 1992
Days to Decision 124 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HCH — Clip, Aneurysm
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.5200