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FDA 510(k)

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

K-Number: K250949 · 2025-07-16

ApplicantOlympus Medical Systems Corporation
Decision Date2025-07-16
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-07-16 under approval number K250949. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is a medical device that received FDA 510(k) clearance on 2025-07-16. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K250949.

When was Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) approved by the FDA?

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) received FDA 510(k) clearance on 2025-07-16, under approval number K250949.

What company makes Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is manufactured by Olympus Medical Systems Corporation.

What is the FDA product code for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

The FDA product code for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is ODC.

Other Devices by Olympus Medical Systems Corporation

K211838Ultrasonic Bipolar Generator USG-410 with accessories K221557Visera Hysterovideoscope Olympus HYF Type V K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) K242357Water Container (MAJ-901); Water Container (MAJ-902)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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