510(k) K243596
K243596 is an FDA 510(k) premarket notification submitted by Intuitive Surgical, Inc. for the device "da Vinci SP SureForm 45 Staplers and Reloads (SP1098)". The FDA issued a decision of Substantially Equivalent on March 10, 2025. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. Intuitive Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2025
- Date Received
- November 21, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stapler, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4740
- Review Panel
- SU
- Submission Type
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.