# K101961: Tigerpaw System

- Pathway: 510(k) (Traditional)
- Applicant: Laax, Inc.
- Decided: Oct 29, 2010 after 109 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: 4 generations back to K842066 (1985). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032696: Auto Suture Endoscopic (& Open) TA Surgical Stapler, Auto Suture Endoscopic (& Open) Gia Surgical Stapling Instrument, United States Surgical, A Division of Tyco Healthc (2003) Summary page 1.
- K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement, Synovis Surgical Innovations (2004) Summary page 1.

## Most influential descendants
- K111064: Tigerpaw System II (2011), 1 descendant of its own
- K190884: TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool (2019), 0 descendants of its own

## Indications for use
The TigerPaw® System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

Source page: https://510kreport.com/device/K101961
Methodology: https://510kreport.com/methodology