# K170879: IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 21, 2017 after 181 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: 13 generations back to K930667 (1994). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140553: Endowrist Stapler 45 and Stapler 45 Reloads, Intuitive Surgical, Inc. (2014) Summary page 7.
- K143217: 12 mm & Stapler Bladeless Obturators, Intuitive Surgical, Inc. (2014) Summary page 7.
- K152421: IS4000 Stapler 30 Instrument and Stapler 30 Reloads, Intuitive Surgical, Inc. (2016) Summary page 7.
- K113706: Endowrist Stapler System, Intuitive Surgical, Inc. (2012) Summary page 7.
- K171388: EndoWrist Stapler 45 System and Stapler 45 Reloads, Intuitive Surgical, Inc. (2017). Cleared while this submission was under review Summary page 7.

## 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 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). The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model 1S4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model 1S4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The devices can be used with staple line or tissue buttressing material.

Source page: https://510kreport.com/device/K170879
Methodology: https://510kreport.com/methodology