# K102916: G-Cath Tissue Anchor Delivery Catheter

- Pathway: 510(k) (Special)
- Applicant: Usgi Medical
- Decided: Oct 20, 2010 after 19 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944415 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061276: G-Prox Endoscopic Grasper, Usgi Medical (2006) Summary page 1.
- K100251: G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333, Usgi Medical (2010) Summary page 1.

## Indications for use
The g-Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.

Source page: https://510kreport.com/device/K102916
Methodology: https://510kreport.com/methodology