FDA 510(k)

CleverLock Guidewire Locking Device and Biopsy Cap

Número K: K190164 · 2019-04-04

RequerenteOlympus Surgical Technologies America

Data da decisão2019-04-04

Código do produtoODC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CleverLock Guidewire Locking Device and Biopsy Cap is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K190164. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CleverLock Guidewire Locking Device and Biopsy Cap?

CleverLock Guidewire Locking Device and Biopsy Cap is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K190164.

When did CleverLock Guidewire Locking Device and Biopsy Cap receive FDA 510(k) clearance?

CleverLock Guidewire Locking Device and Biopsy Cap received FDA 510(k) clearance on 2019-04-04, under 510(k) number K190164.

Who is the listed applicant for CleverLock Guidewire Locking Device and Biopsy Cap?

The FDA 510(k) record lists Olympus Surgical Technologies America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CleverLock Guidewire Locking Device and Biopsy Cap?

The FDA product code for CleverLock Guidewire Locking Device and Biopsy Cap is ODC.

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Fonte oficial

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