# K021701: Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60

- Pathway: 510(k) (Special)
- Applicant: Power Medical Interventions, Inc.
- Decided: Jun 21, 2002 after 29 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.
5 later devices descend from it; 2 cite it directly.
0 of 12 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 2.

## Most influential descendants
- K022313: Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads, Models RALC30V, RALC45V & RALC60V (2002), 3 descendants of its own
- K073148: Idrives, Idrivec, Idrivef with Vascular Indications (2007), 1 descendant of its own
- K091215: Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument (2009), 0 descendants of its own
- K081826: Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads, Models I30V, I45V, 160V, IR30V (2008), 0 descendants of its own
- K052910: Power Right Angle Linear Cutter Digital Loading Unit with Reloads (2005), 0 descendants of its own

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0394-2010: 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 SurgASSISTTMSystem Right Angle Linear Cutter Digital Loading UnitTM (DLU) with Reloads has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Source page: https://510kreport.com/device/K021701
Methodology: https://510kreport.com/methodology