# K071708: I45, I45S, I60, and I60S

- Pathway: 510(k) (Traditional)
- Applicant: Power Medical Interventions, Inc.
- Decided: Sep 27, 2007 after 98 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: 6 generations back to K970720 (1997). 26 ancestors in all.
21 later devices descend from it; 6 cite it directly.
0 of 48 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.
- K021249: Surgassist Flexshaft 2, Model FS2 14, Power Medical Interventions, Inc. (2002) Summary page 1.
- K040720: Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MM, Power Medical Interventions, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K121510: Idrive Ultra Powered Handle Endo Gia Adapter (2012), 8 descendants of its own
- K160176: Signia Stapler (2016), 5 descendants of its own
- K101797: Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB, SCSK, Sonicision Sterilization T (2011), 5 descendants of its own

## Recalls of this device
- Sep 23, 2009 · Not classified · Z-0405-2010: 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 i45, i45S, i60, i60S have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, 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/K071708
Methodology: https://510kreport.com/methodology