# K030653: Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading Units with Reloads

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Mar 31, 2003 after 28 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: 3 generations back to K970720 (1997). 21 ancestors in all.
46 later devices descend from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020719: Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and Green Reload Cartridges, Power Medical Interventions, Inc. (2002)
- K020779: Proximate and Endopath Linear Cutters and Staplers, Ethicon Endo-Surgery, Inc. (2002) Summary page 2.

## Most influential descendants
- K040398: Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads (2004), 45 descendants of its own
- K040720: Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM (2004), 25 descendants of its own
- K071708: I45, I45S, I60, and I60S (2007), 21 descendants of its own
- K093679: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide  Model Various LAA0 (2010), 18 descendants of its own
- K122276: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip (2012), 15 descendants of its own

## Indications for use
The SurgASSIST Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Source page: https://510kreport.com/device/K030653
Methodology: https://510kreport.com/methodology