BERNSTEIN(TM) UTERINE MANIPULATOR— 510(k) K932394

Substantially Equivalent

Gm Engineering, Inc.

FDA 510(k) clearance K932394 for BERNSTEIN(TM) UTERINE MANIPULATOR, Substantially Equivalent on 1995-01-26. Applicant: Gm Engineering, Inc..

Clearance details

Applicant: Gm Engineering, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 1993-05-18
Decision date: 1995-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Verne, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.