# K113706: Endowrist Stapler System

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Oct 17, 2012 after 306 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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: 11 generations back to K930667 (1994). 46 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 1.
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009) Summary page 1.

## Most influential descendants
- K171388: EndoWrist Stapler 45 System and Stapler 45 Reloads (2017), 1 descendant of its own
- K170879: IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories (2017), 0 descendants of its own

## Recalls of this device
- Jun 2, 2014 · Class II · Z-2171-2014: Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range s

## Indications for use
The Intuitive Surgical Endo Wrist® Stapler 45 System and Stapler 45 Reloads are intended to be used with the cia Vinci Si Surgical System (Model 1S3000) for resection, transection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

Source page: https://510kreport.com/device/K113706
Methodology: https://510kreport.com/methodology