Clearance Summary
da Vinci SP SureForm 45 Staplers and Reloads (SP1098) received FDA 510(k) clearance under submission number K243596, sponsored by Intuitive Surgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-03-10.
- Submission: K243596
- Applicant / Sponsor: Intuitive Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 878.4740
- Decision date: 2025-03-10
Classification & Regulation
This clearance is catalogued under FDA product code GAG and 21 CFR 878.4740, within the General Hospital review panel as a Class II device.