# K042492: Hand STC, Model 60MM

- Pathway: 510(k) (Traditional)
- Applicant: Niti Medical Technologies, Ltd.
- Decided: Oct 19, 2004 after 35 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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 K843603 (1984). 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)
- K892927: Proximate Linear Cutter Thick Tissue Inst., ETHICON, Inc. (1989) Summary page 2.
- K843603: Auto Suture Poly Gia Surgical Stapler, United States Surgical, A Division of Tyco Healthc (1984) Summary page 2.
- K892233: Auto Suture (R) Endoscopic Gia (TM) Surgical Stapler, United States Surgical, A Division of Tyco Healthc (1989) Summary page 2.
- K900129: Modified Auto Suture Endoscopic Gia Surg. Stapler*, United States Surgical, A Division of Tyco Healthc (1990) Summary page 2.

## Indications for use
The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.

Source page: https://510kreport.com/device/K042492
Methodology: https://510kreport.com/methodology