# K022313: Surgassist Right Angle Linear Cutter Dlu 30MM, 45MM & 60MM - Vascular with Reloads, Models RALC30V, RALC45V & RALC60V

- Pathway: 510(k) (Traditional)
- Applicant: Power Medical Interventions, Inc.
- Decided: Dec 9, 2002 after 145 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: 3 generations back to K970720 (1997). 8 ancestors in all.
3 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)
- K021701: Surgassist Right Angle Linear Cutter 30MM, 45MM & 60MM, Models RALC30, RALC45 & RALC60, Power Medical Interventions, Inc. (2002) Summary page 2.
- K002398: Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets Compact-FLEX45 NO-Knife Articulating, Ethicon Endo-Surgery, Inc. (2000) Summary page 2.

## Most influential descendants
- 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

## Indications for use
The SurgASSISTTM Right Angle Linear Cutter Digital Loading UnitTM, 30 mm, 45 mm and 60 mm, Vascular with Reloads has applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for transection, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.

Source page: https://510kreport.com/device/K022313
Methodology: https://510kreport.com/methodology