# K133499: Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal Circular Staplers for Single Use, Linea

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Beinuo Medical Equipment Co., Ltd.
- Decided: Jan 14, 2014 after 61 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: 6 generations back to K940967 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
5 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101378: Frankenman Surgical Staplers, Suzhou Frankenman Medical Equipment Co., Ltd. (2010) Summary page 1.

## Indications for use
Suzhou Beinuo surgical staplers are indicated for use as follows: -Circular Stapler for Single Use The Suzhou Beinuo Circular Stapler for Single Use is used throughout the alimentary tract for the reconstruction of the alimentary tract and the creation of end-to-end, end-to-side and side-to-side anastomoses. * Hemorrhoidal Circular Stapler for Single Use The Suzhou Beinuo Hermorrhoidal Circular Stapler for Single Use is a Circular Stapler product, with accessories, that is indicated in anorectal surgical procedures for the treatment of hemorrhoids and anorectal wall defects. * Linear Stapler and Reloads for Single Use The Suzhou Beinuo Linear Stapler and Reloads for Single Use (and reloads) is indicated for the closure of tissue in abdominal, gynecological, and thoracic surgical procedures. * Linear Cutter Stapler and Reloads for Single Use The Suzhou Beinuo Linear Cutter Stapler and Reloads for Single Use (and reloads) is indicated for use in the resection, transection and anastomosis of tissue in gastrointestinal, gynecological, and thoracic surgical procedures.

Source page: https://510kreport.com/device/K133499
Methodology: https://510kreport.com/methodology