# K971801: Laparotomy Bladder Neck Suspension Kit

- Pathway: 510(k) (Traditional)
- Applicant: Louisville Laboratories, Inc.
- Decided: Jul 22, 1997 after 68 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932553 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963076: Laparoscopic Bone Anchored Urethropexy Instrument Tray, Louisville Laboratories, Inc. (1997) Summary page 1.
- K932553: Disposable Suture Placement System, Laurus Medical Corp. (1994) Summary page 1.

## Most influential descendants
- K982626: Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit Model UM-250, Laparoscopic BURCH0 (1998), 0 descendants of its own

## Indications for use
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit is indicated for urethropexy procedures for bladder neck suspension to correct female stress incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K971801
Methodology: https://510kreport.com/methodology