510(k) clearance
da Vinci Surgical System, Model IS5000
- 510(k) number
- K261823
- Applicant
- Intuitive Surgical, Inc.
- Decision date
- Sep 8, 2026
- Date received
- Jun 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NAY
- Device type
- System, Surgical, Computer Controlled Instrument
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Sunnyvale, CA, US