# K241638: 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 10, 2024 after 95 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: 10 generations back to K051002 (2005). 18 ancestors in all.
No later device cites it as a predicate yet.
5 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211997: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads, Intuitive Surgical, Inc. (2021) Summary page 6.
- K222839: EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System, Intuitive Surgical, Inc. (2023) Summary page 6.

## 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 8mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection and transection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

Source page: https://510kreport.com/device/K241638
Methodology: https://510kreport.com/methodology