# K053482: Superstitch GW, Models 06-15-04-GW, 08-15-04-GW

- Pathway: 510(k) (Special)
- Applicant: Sutura, Inc.
- Decided: Dec 27, 2005 after 13 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sutura's SuperStitch Vascular Suturing Device: named in the summary without a submission number

## Indications for use
The SuperStitch GW is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures, The SuperStitch GW is not intended for blind vascular closure.

Source page: https://510kreport.com/device/K053482
Methodology: https://510kreport.com/methodology