# K170508: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 10, 2017 after 17 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: 2 generations back to K033269 (2003). 3 ancestors in all.
12 later devices descend from it; 4 cite it directly.
3 of 16 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 4.
- K152421: IS4000 Stapler 30 Instrument and Stapler 30 Reloads, Intuitive Surgical, Inc. (2016) Summary page 4.

## Most influential descendants
- K173721: SureForm 60 and SureForm 60 Reloads (2018), 6 descendants of its own
- K183224: SureForm 45, SureForm 45 Reloads (2019), 5 descendants of its own
- K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload (2019), 4 descendants of its own
- K181395: Universal Cannula Seal (5-12 mm) (2018), 4 descendants of its own
- K231358: Universal Seal (5-12 mm) (2023), 3 descendants of its own

## Indications for use
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System 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 a compatible da Vinci Surgical System 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 device can be used with staple line or tissue buttressing material.

Source page: https://510kreport.com/device/K170508
Methodology: https://510kreport.com/methodology