# K143217: 12 mm & Stapler Bladeless Obturators

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 3, 2014 after 23 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: 1 generation back to K140553 (2014). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## 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, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) 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).

Source page: https://510kreport.com/device/K143217
Methodology: https://510kreport.com/methodology