XSTAT P15— 510(k) K253290

Substantially Equivalent

Revmedx, Inc.

FDA 510(k) clearance K253290 for XSTAT P15, Substantially Equivalent on 2025-11-12. Applicant: Revmedx, Inc..

Clearance details

Applicant: Revmedx, Inc.
Product code: Code PGZ
Advisory panel: General, Plastic Surgery
Date received: 2025-09-29
Decision date: 2025-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilsonville, OR, US

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