# K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 12, 2019 after 87 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K051002 (2005). 15 ancestors in all.
4 later devices descend from it; 3 cite it directly.
5 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183224: SureForm 45, SureForm 45 Reloads, Intuitive Surgical (2019) Summary page 4.
- K170508: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads, Intuitive Surgical, Inc. (2017) Summary page 4.

## Most influential descendants
- K211997: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads (2021), 2 descendants of its own
- K222839: EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System (2023), 1 descendant of its own
- K243596: da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (2025), 0 descendants of its own
- 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 17, 2022 · Class II · Z-0999-2022: As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in plac

## Indications for use
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).

Source page: https://510kreport.com/device/K190999
Methodology: https://510kreport.com/methodology