FDA 510(k)

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

Número K: K251859 · 2025-10-03

RequerenteOlympus Medical Systems Corporation

Data da decisão2025-10-03

Código do produtoODG

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Olympus Medical Systems Corporation como candidato(a)

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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Dispositivos Relacionados (Código: ODG)

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Fonte oficial

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