# K061649: Power Circular Stapler Digital Loading Unit with and Without Sheath

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Sep 1, 2006 after 80 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: 1 generation back to K003277 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Power 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/K061649
Methodology: https://510kreport.com/methodology