Cleared Traditional

FORCEPS, BIOPSY, NON-ELECTRIC

K952863 · Annex Medical, Inc. · Gastroenterology & Urology
Jul 1995
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K952863 is an FDA 510(k) clearance for the FORCEPS, BIOPSY, NON-ELECTRIC, a Forceps, Biopsy, Non-electric (Class I — General Controls, product code FCL), submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 19, 1995, 27 days after receiving the submission on June 22, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K952863 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1995
Decision Date July 19, 1995
Days to Decision 27 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FCL — Forceps, Biopsy, Non-electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.1075

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