Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)— 510(k) K250949
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K250949 for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444), Substantially Equivalent on 2025-07-16. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code ODC
- 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
Recent devices under product code ODC
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Recalls naming K250949
K-number listed on FDA's recall record- Z-1610-2026 — Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
- Z-1611-2026 — Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250949.
Data sourced from openFDA. This site is unofficial and independent of the FDA.