Cleared Traditional

BIOPSY FORCEPS

K892252 · Zinnanti Surgical Instruments, Inc. · Gastroenterology & Urology
Oct 1989
Decision
182d
Days
Class 1
Risk

About This 510(k) Submission

K892252 is an FDA 510(k) clearance for the BIOPSY FORCEPS, a Forceps, Biopsy, Non-electric (Class I — General Controls, product code FCL), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on October 3, 1989, 182 days after receiving the submission on April 4, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K892252 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1989
Decision Date October 03, 1989
Days to Decision 182 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

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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