FDA 510(k)

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

N.º K: K250949 · 2025-07-16

SolicitanteOlympus Medical Systems Corporation

Fecha de decisión2025-07-16

Código de productoODC

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K250949.

When did Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) receive FDA 510(k) clearance?

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

Who is the listed applicant for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

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Otros registros que enlistan a Olympus Medical Systems Corporation como solicitante

K260824Gastrointestinal Videoscope Olympus GIF-2T1500 K260856Disposable Distal Attachment D-201-13404 K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LB K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.