FDA 510(k)

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

Número K: K261183 · 2026-07-31

RequerenteOlympus Medical Systems Corporation

Data da decisão2026-07-31

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 2026-07-31 under 510(k) number K261183. 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 2026-07-31. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K261183.

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 2026-07-31, under 510(k) number K261183.

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K260856Disposable Distal Attachment D-201-13404 K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500 K261260HD Camera Head OLYMPUS CH-S200-08-LB K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D K250993Single Use Cytology Brush V (BC-V600P-3010)

Ver todos os 36 dispositivos →

Dispositivos Relacionados (Código: ODG)

K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation K251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation K251542InstaFANOnepass Medical , Ltd.K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, Inc.K223616Dispositivo de Biópsia por Agulha Fina de Ultrassonografia Endoscópica Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.