# K963076: Laparoscopic Bone Anchored Urethropexy Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Louisville Laboratories, Inc.
- Decided: Apr 4, 1997 after 240 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
No predicates in its family tree.
10 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971797: Laparoscopic Bladder Neck Suspension Kit (1997), 5 descendants of its own
- 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
- K971796: Laparotomy Bladder Neck Suspension Kit with Bone Anchors (1997), 1 descendant of its own

Source page: https://510kreport.com/device/K963076
Methodology: https://510kreport.com/methodology