Atlas FDA

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)

FDA 510(k) clearance K250949 · decided 2025-07-16

Clearance details

K-number
K250949
Device name
Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
Applicant
Olympus Medical Systems Corporation
Decision
Substantially Equivalent
Date received
2025-03-28
Decision date
2025-07-16
Days to decision
110 days
Clearance type
Traditional
Product code
ODC
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hachioji-Shi, JP
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. recall (Z-1610-2026)Olympus Corporation of the Americas2026-03-20
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. recall (Z-1611-2026)Olympus Corporation of the Americas2026-03-20