Cleared Traditional

ENDOMED LAPAROSCOPY INSTRUMENTS

K921686 · Buckman Co., Inc. · Obstetrics & Gynecology
Mar 1994
Decision
721d
Days
Class 2
Risk

About This 510(k) Submission

K921686 is an FDA 510(k) clearance for the ENDOMED LAPAROSCOPY INSTRUMENTS, a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code KNF), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on March 30, 1994, 721 days after receiving the submission on April 8, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number K921686 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1992
Decision Date March 30, 1994
Days to Decision 721 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code KNF — Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4160

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