FDA 510(k)

Single Use Cytology Brush BC-205D

Número K: K190293 · 2019-08-02

Data da decisão2019-08-02

Código do produtoBTG

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single Use Cytology Brush BC-205D 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 2019-08-02 under 510(k) number K190293. The device is classified under product code BTG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single Use Cytology Brush BC-205D?

Single Use Cytology Brush BC-205D is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K190293.

When did Single Use Cytology Brush BC-205D receive FDA 510(k) clearance?

Single Use Cytology Brush BC-205D received FDA 510(k) clearance on 2019-08-02, under 510(k) number K190293.

Who is the listed applicant for Single Use Cytology Brush BC-205D?

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 Single Use Cytology Brush BC-205D?

The FDA product code for Single Use Cytology Brush BC-205D is BTG.

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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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Dispositivos Relacionados (Código: BTG)

K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation K182927Pulmonary Cytology BrushHobbs Medical, Inc.

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