# K120179: Reach Surgical Staplers

- Pathway: 510(k) (Traditional)
- Applicant: Reach Surgical, Inc.
- Decided: May 23, 2012 after 124 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: 5 generations back to K940967 (1994). 17 ancestors in all.
17 later devices descend from it; 6 cite it directly.
6 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090821: Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L, Frankenman International Limited (2009) Summary page 3.
- K081146: Echelon Endoscopic Linear Cutters (Articulating and Straight), Ethicon Endo-Surgery, LLC (2008) Summary page 3.

## Most influential descendants
- K131511: Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorr (2013), 14 descendants of its own
- K141367: LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC Series Linear Cutter and Reloads (2014), 7 descendants of its own
- 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

## Indications for use
The Circular Staplers with Staples 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. The Linear Staplers with Single Use Loading Units have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The Procedure Sets for Prolapse and Hemorrhoids have application for general surgical treatment of hemorrhoids. The Endoscopic Linear Cutting Staplers with Single Use Loading Units have applications in general, 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. The Linear Cutting Staplers with Single Use Loading Units have application in abdominal, gynecological, thoracic and pediatric surgery transeclion, resection, and the creation of anastormoses.

Source page: https://510kreport.com/device/K120179
Methodology: https://510kreport.com/methodology