# K181620: Endoscopic Linear Cutting Staplers and Loading Units for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Ezisurg (Suzhou) Medical Co., Ltd.
- Decided: Sep 18, 2018 after 90 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). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 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 6.
- K061156: Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and Endopath & Proximate Linear Cutters, Ethicon Endo-Surgery, Inc. (2006) Summary page 6.

## Indications for use
The device is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

Source page: https://510kreport.com/device/K181620
Methodology: https://510kreport.com/methodology