FDA 510(k)

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

K-번호: K261183 · 2026-07-31

결정일2026-07-31

제품 코드ODG

자문 위원회GU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Olympus Medical Systems Corporation를 신청인으로 등재한 기타 기록

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)

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