# K020719: Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and Green Reload Cartridges

- Pathway: 510(k) (Traditional)
- Applicant: Power Medical Interventions, Inc.
- Decided: May 10, 2002 after 66 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 K970720 (1997). 6 ancestors in all.
47 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012809: Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45, Power Medical Interventions, Inc. (2001) Summary page 1.
- K980815: Endopath EZ45 Endoscopic Linear Cutter, Ethicon Endo-Surgery, Inc. (1998) Summary page 1.

## Most influential descendants
- K030653: Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading Units with Reloads (2003), 46 descendants of its own
- 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

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0396-2010: 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 Straight Linear Cutter DLU has 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/K020719
Methodology: https://510kreport.com/methodology