# K141367: LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC Series Linear Cutter and Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Touchstone International Medical Science Co., Ltd.
- Decided: Jul 25, 2014 after 63 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: 7 generations back to K940967 (1994). 25 ancestors in all.
7 later devices descend from it; 2 cite it directly.
6 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131511: Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorr, Changzhou Sinolinks Medical Innovation Co., Ltd. (2013) Summary page 6.
- K120179: Reach Surgical Staplers, Reach Surgical, Inc. (2012) Summary page 6.

## Most influential descendants
- K173443: AEON Endoscopic Stapler (2018), 5 descendants of its own
- K182380: AEON Endoscopic Stapler (2018), 4 descendants of its own
- K201882: AEON Endoscopic Stapler (2020), 3 descendants of its own
- K222210: AEON Endoscopic Stapler (2023), 2 descendants of its own
- K251482: AEON™ Endoscopic Powered Stapler (2025), 0 descendants of its own

## Indications for use
The LS Series Linear Stapler and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The CLC Series Curved Linear Cutter and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures. The LC Series Linear Cutter and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses. The ELC Series Endoscopic Linear Cutter and Single Use Loading Unit have applications in general, abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Source page: https://510kreport.com/device/K141367
Methodology: https://510kreport.com/methodology