# K171388: EndoWrist Stapler 45 System and Stapler 45 Reloads

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: May 31, 2017 after 20 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K930667 (1994). 47 ancestors in all.
1 later device descends from it; 1 cites 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)
- K113706: Endowrist Stapler System, Intuitive Surgical, Inc. (2012) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Intuitive Surgical EndoWrist Stapler 45 System and Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line and tissue buttressing material (natural or synthetic).

Source page: https://510kreport.com/device/K171388
Methodology: https://510kreport.com/methodology