Cleared Traditional

MICRO-FRANCE TROCARS AND ACCESSORIES

K993653 · Xomed, Inc. · Obstetrics & Gynecology
Jun 2000
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K993653 is an FDA 510(k) clearance for the MICRO-FRANCE TROCARS AND ACCESSORIES, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 9, 2000, 224 days after receiving the submission on October 29, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K993653 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1999
Decision Date June 09, 2000
Days to Decision 224 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HET — Laparoscope, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1720

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