FDA 510(k)

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

N.º K: K251859 · 2025-10-03

SolicitanteOlympus Medical Systems Corporation

Fecha de decisión2025-10-03

Código de productoODG

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) 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 2025-10-03 under 510(k) number K251859. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)?

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K251859.

When did EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) receive FDA 510(k) clearance?

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K251859.

Who is the listed applicant for EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)?

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 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)?

The FDA product code for EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) is ODG.

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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

Ver todos los 36 dispositivos →

Dispositivos relacionados (Código: ODG)

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation K251542InstaFANOnepass Medical , Ltd.K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, Inc.K223616Dispositivo de Biopsia por Punción Fina con Ultrasonido Endoscópico Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB)Boston Scientific Corporation

Fuente oficial

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