# K201639: Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
- Decided: May 27, 2021 after 345 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: 10 generations back to K842066 (1985). 36 ancestors in all.
No later device cites it as a predicate yet.
4 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103470: Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal Circular Stapler; Panther Linear Stap, B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (2011) Summary page 6.
- K142577: PANTHER Endo Linear Cutter Staplers with Single Use Loading Units, B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (2015) Summary page 6.

## Indications for use
The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease. The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue. The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.

Source page: https://510kreport.com/device/K201639
Methodology: https://510kreport.com/methodology