FDA 510(k)

core nova Complete Operating Room Endoscopy

Numéro K : K151282 · 2016-01-12

DemandeurRichard Wolf Medical Instruments Corp.

Date de décision2016-01-12

Code produitODA

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

core nova Complete Operating Room Endoscopy is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K151282. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the core nova Complete Operating Room Endoscopy?

core nova Complete Operating Room Endoscopy is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K151282.

When did core nova Complete Operating Room Endoscopy receive FDA 510(k) clearance?

core nova Complete Operating Room Endoscopy received FDA 510(k) clearance on 2016-01-12, under 510(k) number K151282.

Who is the listed applicant for core nova Complete Operating Room Endoscopy?

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

What is the FDA product code for core nova Complete Operating Room Endoscopy?

The FDA product code for core nova Complete Operating Room Endoscopy is ODA.

Essais cliniques associés

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Source officielle

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