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

Name: FDA 510(k) clearance K971796
Creator: U.S. Food and Drug Administration
Published: 1997-08-12

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.. Device class: 2.

Clearance details

Applicant: Louisville Laboratories, Inc.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
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

Download summary PDF View on FDA.gov ↗

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K980123 — CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET1998-03-09
K971791 — VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION1997-07-30
K971802 — VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION1997-07-30
K971797 — LAPAROSCOPIC BLADDER NECK SUSPENSION KIT1997-07-22
K971801 — LAPAROTOMY BLADDER NECK SUSPENSION KIT1997-07-22

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.