Cleared Traditional

BERNSTEIN(TM) UTERINE MANIPULATOR

K932394 · Gm Engineering, Inc. · Obstetrics & Gynecology
Jan 1995
Decision
618d
Days
Class 2
Risk

About This 510(k) Submission

K932394 is an FDA 510(k) clearance for the BERNSTEIN(TM) UTERINE MANIPULATOR, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on January 26, 1995, 618 days after receiving the submission on May 18, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K932394 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1993
Decision Date January 26, 1995
Days to Decision 618 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code LKF — Cannula, Manipulator/injector, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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