K253556
- 510(k) number
- K253556
- Device name
- da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2026-01-16
- Date received
- 2025-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K253556.pdf
Official FDA record: K253556
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.