510(k) K904079— BARD UTERINE MANIPULATOR

Substantially Equivalent

C.R. Bard, Inc.

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 1990-09-05
Decision date: 1991-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

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.