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FDA 510(k)

core nova Complete Operating Room Endoscopy

K-Number: K151282 · 2016-01-12

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date2016-01-12
Product CodeODA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Richard Wolf Medical Instruments Corp.. The 510(k) number is K151282.

When was core nova Complete Operating Room Endoscopy approved by the FDA?

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

What company makes core nova Complete Operating Room Endoscopy?

core nova Complete Operating Room Endoscopy is manufactured by Richard Wolf Medical Instruments Corp..

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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