# K222839: EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 16, 2023 after 177 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K051002 (2005). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170508: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads, Intuitive Surgical, Inc. (2017) Summary page 5.
- K183224: SureForm 45, SureForm 45 Reloads, Intuitive Surgical (2019) Summary page 5.
- K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload, Intuitive Surgical, Inc. (2019) Summary page 5.
- K173721: SureForm 60 and SureForm 60 Reloads, Intuitive Surgical (2018) Summary page 5.
- K211997: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads, Intuitive Surgical, Inc. (2021) Summary page 5.

## Most influential descendants
- K241638: 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads (2024), 0 descendants of its own

## Recalls of this device
- Mar 11, 2026 · Class I · Z-1855-2026: Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

## 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. The Intuitive Surgical SureForm 60, SureForm 60 Reloads and accessories are intended to be used with a compatible da Vinci System for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other Stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic). The Intuitive Surgical 8 mm SureForm 30 Curved-Tip and 8 mm SureForm 30 Reloads and accessories are intended to be used with a compatible da Vinci Surgical System for resection, transection of vasculature and tissue, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric Surgery.

Source page: https://510kreport.com/device/K222839
Methodology: https://510kreport.com/methodology