LAPAROTOMY BLADDER NECK SUSPENSION KIT— 510(k) K971801

Substantially Equivalent

Louisville Laboratories, Inc.

FDA 510(k) clearance K971801 for LAPAROTOMY BLADDER NECK SUSPENSION KIT, Substantially Equivalent on 1997-07-22. Applicant: Louisville Laboratories, Inc..

Clearance details

Applicant: Louisville Laboratories, Inc.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-15
Decision date: 1997-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.