# K982626: Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit Model UM-250, Laparoscopic BURCH0

- Pathway: 510(k) (Special)
- Applicant: Medworks Corp.
- Decided: Aug 20, 1998 after 23 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: 2 generations back to K932553 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971791: Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension, Louisville Laboratories, Inc. (1997) Summary page 1.
- K971796: Laparotomy Bladder Neck Suspension Kit with Bone Anchors, Louisville Laboratories, Inc. (1997) Summary page 1.
- K971797: Laparoscopic Bladder Neck Suspension Kit, Louisville Laboratories, Inc. (1997) Summary page 1.
- K963076: Laparoscopic Bone Anchored Urethropexy Instrument Tray, Louisville Laboratories, Inc. (1997) Summary page 1.
- K971801: Laparotomy Bladder Neck Suspension Kit, Louisville Laboratories, Inc. (1997) Summary page 1.
- K971802: Vaginal Suturing Kit for Bladder Neck Suspension, Louisville Laboratories, Inc. (1997) Summary page 1.

## Indications for use
MedWorks Urinary Incontinence Surgical Devices are indicated for use in urethropexy surgical procedures for bladder neck suspension to correct female stress urinary incontinence due to urethral hypermobility.

Source page: https://510kreport.com/device/K982626
Methodology: https://510kreport.com/methodology