FDA 510(k)

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

N.º K: K143153 · 2016-01-15

SolicitanteOlympus Medical Systems Corp.

Fecha de decisión2016-01-15

Código de productoFDT

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V 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 2016-01-15 under 510(k) number K143153. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K143153.

When did EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V receive FDA 510(k) clearance?

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V received FDA 510(k) clearance on 2016-01-15, under 510(k) number K143153.

Who is the listed applicant for EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

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 II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V?

The FDA product code for EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V is FDT.

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Otros registros que enlistan a Olympus Medical Systems Corp. como solicitante

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Tipo de Sujeción Actuada en la Frente S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Tipo de Sujeción Actuada en la Frente S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Tipo de Sujeción Actuada en la 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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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.