# K040024: Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Feb 4, 2004 after 28 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 K920752 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K032701: Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33), Power Medical Interventions, Inc. (2003) Summary page 1.

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0401-2010: 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® Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Source page: https://510kreport.com/device/K040024
Methodology: https://510kreport.com/methodology