# K021249: Surgassist Flexshaft 2, Model FS2 14

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: May 15, 2002 after 26 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890841 (1989). 4 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003277: Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33, Powermed, Inc. (2000) Summary page 1.
- K012809: Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45, Power Medical Interventions, Inc. (2001) Summary page 7.

## Most influential descendants
- K071708: I45, I45S, I60, and I60S (2007), 21 descendants of its own
- K073001: Idrives, Idrivec, Idrivef (2007), 11 descendants of its own
- K102325: Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) (2010), 9 descendants of its own
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (2012), 8 descendants of its own
- K160176: Signia Stapler (2016), 5 descendants of its own

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0397-2010: Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some insta

## Indications for use
The SurgASSIST™ System with Circular Stapler Digital Loading Unit™ (DLU), has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis. The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomosis.

Source page: https://510kreport.com/device/K021249
Methodology: https://510kreport.com/methodology