Cleared Traditional

REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS

K022751 · Medical Device Services · Gastroenterology & Urology
Nov 2002
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K022751 is an FDA 510(k) clearance for the REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS, a Forceps, Biopsy, Electric (Class II — Special Controls, product code KGE), submitted by Medical Device Services (St. George, US). The FDA issued a Cleared decision on November 4, 2002, 77 days after receiving the submission on August 19, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K022751 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2002
Decision Date November 04, 2002
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KGE — Forceps, Biopsy, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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