# 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

- Pathway: 510(k) (Traditional)
- Applicant: Frankenman International Limited
- Decided: Jun 10, 2009 after 76 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: 4 generations back to K940967 (1994). 13 ancestors in all.
21 later devices descend from it; 3 cite it directly.
5 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920752: Endopath Ils Endoscopic Circular Stapler, ETHICON, Inc. (1992) Summary page 1.
- K024275: Auto Suture Premium Plus Ceea Disposable Stapler, United States Surgical, A Division of Tyco Healthc (2003) Summary page 1.
- K020804: Auto Suture Premium Plus Ceea Disposable Stapler, United States Surgical, A Division of Tyco Healthc (2002) Summary page 1.
- K001895: Auto Suture Premium Plus Ceea Disposable Stapler, United States Surgical, A Division of Tyco Healthc (2000) Summary page 1.
- K051301: Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Ethicon Endo-Surgery, Inc. (2005) Summary page 1.
- K991030: Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Ethicon Endo-Surgery, Inc. (1999) Summary page 2.
- K030925: Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Model PPH01, Ethicon Endo-Surgery, Inc. (2003) Summary page 2.
- K822345: Disposable Linear Stapler (LSF), ETHICON, Inc. (1982) Summary page 2.
- K905106: Auto Suture (R) TA Premium (TM) Urology Stapler, United States Surgical, A Division of Tyco Healthc (1991) Summary page 2.
- K801590: Auto Suture Disposable Gia Surg. Stapler, United States Surgical, A Division of Tyco Healthc (1980) Summary page 2.
- K951546: Endopath and Proximate Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (1995) Summary page 2.
- (no number) Auto Suture Circular Surgical Staplers: named in the summary without a submission number

## Most influential descendants
- K120179: Reach Surgical Staplers (2012), 17 descendants of its own
- 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

## Indications for use
The Chex Family of Staplers and there intended uses are as follows: 1. Single Use Curved Intraluminal Circular Stapler The CHEX TM Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques. 2. Circular Stapler for Rectal Prolapse and Hemorrhoid The CHEX TM Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position. 3. Single Use Reloadable Linear Stapler The CHEX TM Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. 4. Single Use Reloadable Linear Cutter Stapler The CHEX TM Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.

Source page: https://510kreport.com/device/K090821
Methodology: https://510kreport.com/methodology