# K243596: da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 10, 2025 after 109 days
- Product code: GAG (Stapler, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K051002 (2005). 16 ancestors in all.
No later device cites it as a predicate yet.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload, Intuitive Surgical, Inc. (2019) Summary page 6.
- K183224: SureForm 45, SureForm 45 Reloads, Intuitive Surgical (2019) Summary page 6.

## Indications for use
The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.

Source page: https://510kreport.com/device/K243596
Methodology: https://510kreport.com/methodology