# K991567: Shelhigh NO-React Tissue Repair Patch/Uropatch.

- Pathway: 510(k) (Traditional)
- Applicant: Shelhigh, Inc.
- Decided: Jul 14, 1999 after 70 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964467 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974914: Shelhigh NO-React Pericardial Patches, Shelhigh, Inc. (1998) Summary page 1.
- K981756: Shelhigh NO-React Pneumopledgets, Shelhigh, Inc. (1998) Summary page 1.

## Indications for use
Tissue repair patch, for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm, femoral, incisional, inguinal, lumbar, and umbilical hernia.

Source page: https://510kreport.com/device/K991567
Methodology: https://510kreport.com/methodology