# K063462: Neatstitch Neatclose Suturing Device

- Pathway: 510(k) (Traditional)
- Applicant: Neat Stitch, Ltd.
- Decided: Jan 12, 2007 after 58 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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 K900198 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011105: Suturtek Fastclose Fascia Closure Device, Qrc Consulting (2001)
- K981531: Suture Placement Device and Accessories, Lsi Solutions (1998) Summary page 1.
- K040282: Atramat and Sorb-Fast Polyglycolic Acid, Internacional Farmaceutica, S.A. DE C.V. (2004) Summary page 1.

## Indications for use
The NeatStitch NeatClose suturing device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures.

Source page: https://510kreport.com/device/K063462
Methodology: https://510kreport.com/methodology