Single-Use Biopsy Valve (MAJ-1555)— 510(k) K251997

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K251997 for Single-Use Biopsy Valve (MAJ-1555), Substantially Equivalent on 2025-09-25. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code OCX
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-27
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

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