Cleared Traditional

K760961 - OCCLUSION CLIPS (FDA 510(k) Clearance)

Nov 1976
Decision
14d
Days
Class 2
Risk

K760961 is an FDA 510(k) clearance for the OCCLUSION CLIPS. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).

Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1976, 14 days after receiving the submission on October 29, 1976.

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

Submission Details

510(k) Number K760961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1976
Decision Date November 12, 1976
Days to Decision 14 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -

Device Classification

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