FDA 510(k)

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

Número K: K250701 · 2025-06-05

Data da decisão2025-06-05

Código do produtoFDT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K250701. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K250701.

When did Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) receive FDA 510(k) clearance?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) received FDA 510(k) clearance on 2025-06-05, under 510(k) number K250701.

Who is the listed applicant for Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)?

The FDA product code for Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) is FDT.

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

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Tipo de Puxador Ativado na Frente S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Tipo de Puxador Ativado na Frente S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Tipo de Puxador Ativado na Frente S (TB-0520FCS)K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

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Fonte oficial

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