Decision Date2018-03-30
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
OLYMPUS URF-V2/V2R 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 2018-03-30 under 510(k) number K172246. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OLYMPUS URF-V2/V2R?
OLYMPUS URF-V2/V2R is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K172246.
When did OLYMPUS URF-V2/V2R receive FDA 510(k) clearance?
OLYMPUS URF-V2/V2R received FDA 510(k) clearance on 2018-03-30, under 510(k) number K172246.
Who is the listed applicant for OLYMPUS URF-V2/V2R?
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 OLYMPUS URF-V2/V2R?
The FDA product code for OLYMPUS URF-V2/V2R is FGB.
Other records listing Olympus Medical Systems Corp. as applicant
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.