FDA 510(k)

NAVIRFA Scope

K-Number: K211529 · 2022-05-05

Decision Date2022-05-05

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NAVIRFA Scope is the device name listed in this FDA 510(k) record. The listed applicant is Navifus Corporation. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K211529. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIRFA Scope?

NAVIRFA Scope is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Navifus Corporation. The 510(k) number is K211529.

When did NAVIRFA Scope receive FDA 510(k) clearance?

NAVIRFA Scope received FDA 510(k) clearance on 2022-05-05, under 510(k) number K211529.

Who is the listed applicant for NAVIRFA Scope?

The FDA 510(k) record lists Navifus Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIRFA Scope?

The FDA product code for NAVIRFA Scope is IYO.

Related Devices (Code: IYO)

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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.