# K040720: Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM

- Pathway: 510(k) (Traditional)
- Applicant: Power Medical Interventions, Inc.
- Decided: Jun 3, 2004 after 76 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: 5 generations back to K970720 (1997). 24 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 50 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) Summary page 1.
- K040398: Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads, Power Medical Interventions, Inc. (2004). Cleared while this submission was under review Summary page 1.
- K032696: Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) Gia Surgical Stapling Instrument, United States Surgical, A Division of Tyco Healthc (2003) Summary page 2.

## Most influential descendants
- K071708: I45, I45S, I60, and I60S (2007), 21 descendants of its own
- K052415: Power Linear Cutter Reusable Digital Loading Units with Reloads (2005), 15 descendants of its own
- K063746: Power Extenders Model# PEC200, PES200,PES200S (2007), 13 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

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0398-2010: 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® Computer Mediated Linear Cutter Digital Loading Units® have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

Source page: https://510kreport.com/device/K040720
Methodology: https://510kreport.com/methodology