IRISeg— 510(k) K251763

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K251763 for IRISeg, Substantially Equivalent on 2025-12-16. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-06-09
Decision date: 2025-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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