# K160969: ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler

- Pathway: 510(k) (Traditional)
- Applicant: Shinemed, LLC
- Decided: Dec 12, 2016 after 250 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: 11 generations back to K842066 (1985). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 5.
- K062850: Autosuture Circular Eea Surgical Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 5.

## Indications for use
ShineMed Reloadable Open Cutting Staplers (ROCS) have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. ShineMed Curved Intraluminal Cutting Staplers (CICS) have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.

Source page: https://510kreport.com/device/K160969
Methodology: https://510kreport.com/methodology