LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY— 510(k) K963076

Substantially Equivalent

Louisville Laboratories, Inc.

FDA 510(k) clearance K963076 for LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY, Substantially Equivalent on 1997-04-04. Applicant: Louisville Laboratories, Inc..

Clearance details

Applicant: Louisville Laboratories, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1996-08-07
Decision date: 1997-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.