Single-Use Biopsy Valve (MAJ-1555)— 510(k) K251997
Substantially EquivalentOlympus 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. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code OCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.