# K101378: Frankenman Surgical Staplers

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Frankenman Medical Equipment Co., Ltd.
- Decided: Jun 29, 2010 after 43 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). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 16 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.
- K920752: Endopath Ils Endoscopic Circular Stapler, ETHICON, Inc. (1992) Summary page 4.
- K822345: Disposable Linear Stapler (LSF), ETHICON, Inc. (1982) Summary page 4.

## Cited in the summary but kept off the family tree
- K091002: Chex Single Use Reloadable Linear Stapler and Reloads. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133499: Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal Circular Staplers for Single Use, Linea (2014), 0 descendants of its own

## Indications for use
Frankenman Staplers are indicated as follows: Disposable Alimentary Canal Stapler The Frankenman Disposable Alimentary Canal 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. Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid The Frankenman 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. Disposable Reloadable Linear Stapler and Reloads The Frankenman Disposable Reloadable Linear Stapler (and Reloads) is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. Disposable Reloadable Linear Cutter Stapler and Reloads The Frankenman Disposable Reloadlable Linear Cutter Stapler (and Reloads) has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.

Source page: https://510kreport.com/device/K101378
Methodology: https://510kreport.com/methodology