# K971797: Laparoscopic Bladder Neck Suspension Kit

- Pathway: 510(k) (Traditional)
- Applicant: Louisville Laboratories, Inc.
- Decided: Jul 22, 1997 after 68 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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.
5 later devices descend from it; 2 cite it directly.
0 of 8 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 2.
- K932553: Disposable Suture Placement System, Laurus Medical Corp. (1994) Summary page 2.
- (no number) surgical techniques that have been performed for over forty years: named in the summary without a submission number

## Most influential descendants
- K011190: Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System) (2002), 3 descendants of its own
- K020126: Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System) (2002), 2 descendants of its own
- K020952: Surx RF System (2002), 1 descendant of its own
- K042132: Novasys Transurethral RF System (2004), 0 descendants of its own
- 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. Laparoscopic 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/K971797
Methodology: https://510kreport.com/methodology