# K012809: Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45

- Pathway: 510(k) (Traditional)
- Applicant: Power Medical Interventions, Inc.
- Decided: Oct 26, 2001 after 65 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 K890841 (1989). 3 ancestors in all.
66 later devices descend from it; 6 cite it directly.
0 of 70 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.
- K890841: Titanium Staples, ETHICON, Inc. (1989) Summary page 2.
- K913802: Auto Suture (R) Powered Endoscopic Gia (TM) Stapler, United States Surgical, A Division of Tyco Healthc (1991) Summary page 2.

## Most influential descendants
- K020719: Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and Green Reload Cartridges (2002), 47 descendants of its own
- 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
- K021249: Surgassist Flexshaft 2, Model FS2 14 (2002), 22 descendants of its own

## Indications for use
The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Source page: https://510kreport.com/device/K012809
Methodology: https://510kreport.com/methodology