K242318
- 510(k) number
- K242318
- Device name
- da Vinci SP Surgical System (SP1098)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2024-11-26
- Date received
- 2024-08-05
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K242318.pdf
Official FDA record: K242318
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.