LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS— 510(k) K971796

Substantially Equivalent

Louisville Laboratories, Inc.

FDA 510(k) clearance K971796 for LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS, Substantially Equivalent on 1997-08-12. 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: 1997-08-12
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.