IRISeg— 510(k) K251763
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K251763 for IRISeg, Substantially Equivalent on 2025-12-16. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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