# K971791: Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension

- Pathway: 510(k) (Traditional)
- Applicant: Louisville Laboratories, Inc.
- Decided: Jul 30, 1997 after 76 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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. Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension is indicated for urethropexy procedures for bladder neck suspension to correct female stress incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K971791
Methodology: https://510kreport.com/methodology