# K211997: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 10, 2021 after 165 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (1 Class I)
- 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.
2 later devices descend from it; 2 cite 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)
- K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload, Intuitive Surgical, Inc. (2019) Summary page 5.

## Most influential descendants
- 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
- 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.
- Oct 7, 2022 · Class II · Z-0340-2023: Potential staple deployment failure and device fragment generation

## Indications for use
The Intuitive Surgical 8 mm 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/K211997
Methodology: https://510kreport.com/methodology