# K020343: Surgassist System; Wireless Remote Control (Component); Wired Remote Control

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Apr 10, 2002 after 68 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 K890841 (1989). 5 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 19 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.
- K000908: Skylight Imaging System, Adac Laboratories (2000) Summary page 2.
- K012809: Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45, Power Medical Interventions, Inc. (2001) Summary page 3.

## Most influential descendants
- K053510: IR Wireless Foot Switch (2006), 12 descendants of its own
- K083161: Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) (2009), 9 descendants of its own
- K100638: Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214 (2010), 8 descendants of its own
- K152777: Bovie Disposable Bipolar Ablator (2016), 3 descendants of its own
- K161558: Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating,  Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating (2016), 2 descendants of its own

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0395-2010: 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 with Circular Stapler DLU, has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis. The SurgASSIST™ System with Right Angle Cutter Digital Loading Unit has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomosis.

Source page: https://510kreport.com/device/K020343
Methodology: https://510kreport.com/methodology