Cleared Traditional

MALLAWANY ATRAUMATIC TISSUE FORCEPS

K922248 · Numed Technologies, Inc. · Obstetrics & Gynecology
Feb 1994
Decision
645d
Days
Class 2
Risk

About This 510(k) Submission

K922248 is an FDA 510(k) clearance for the MALLAWANY ATRAUMATIC TISSUE FORCEPS, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Numed Technologies, Inc. (Independence, US). The FDA issued a Cleared decision on February 17, 1994, 645 days after receiving the submission on May 13, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K922248 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1992
Decision Date February 17, 1994
Days to Decision 645 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

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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