# K980717: Uromed Sling Kit

- Pathway: 510(k) (Traditional)
- Applicant: Uromed Corp.
- Decided: May 22, 1998 after 87 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 K881224 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933698: 100 Series Endoscopic Grasping Forceps, Cook Urological, Inc. (1994) Summary page 1.
- K881224: Acufex Suture Retriever, Sterile Disposable, Acufex Microsurgical, Inc. (1988) Summary page 1.
- K926036: Acufex Suture Retriever, Acufex Microsurgical, Inc. (1993) Summary page 1.
- (no number) Cook Stamey Needle: named in the summary without a submission number
- (no number) Cook Fascial Dilator: named in the summary without a submission number

## Indications for use
The UroMed Sling Kit is indicated for use by the surgeon for placing a urethral sling. The kit provides instruments to help the surgeon place the sling beneath the urethra. The kit will be used in suburethral sling procedures for female urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K980717
Methodology: https://510kreport.com/methodology