FDA 510(k)

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

Numéro K : K261183 · 2026-07-31

DemandeurOlympus Medical Systems Corporation

Date de décision2026-07-31

Code produitODG

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

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Autres dossiers indiquant Olympus Medical Systems Corporation en tant que demandeur

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)

Voir tous les 36 dispositifs →

Dispositifs connexes (Code : 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.K223616Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation

Source officielle

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