# K963175: Glycar Tissue Repair Patch, Bio-Patch, Uro-Sling

- Pathway: 510(k) (Traditional)
- Applicant: Glycar, Inc.
- Decided: Sep 23, 1996 after 40 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: 1 generation back to K923657 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 1.

## Indications for use
The predicate device, the Peri-Guard™ family of glutaraldehyde-treated bovine pericardium tissue patch has been used for pericardial closures, the repair of abdominal and thoracic wall defects, inguinal, paracolostomy, ventral, paraumbilical, scrotal, femoral and other hernias, urethral slings, reconstruction of pelvic floor, repair of rectal and vaginal prolapse, suture and staple bolsters, pledgets and slings, and other soft tissue repair, reinforcement, and reconstruction without any significant reported patient morbidity or mortality attributed to material failures.

Source page: https://510kreport.com/device/K963175
Methodology: https://510kreport.com/methodology