Decision Date2018-03-29
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
OLYMPUS URF-P6/P6R 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 2018-03-29 under 510(k) number K172298. 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-P6/P6R?
OLYMPUS URF-P6/P6R is a medical device that received FDA 510(k) clearance on 2018-03-29. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K172298.
When did OLYMPUS URF-P6/P6R receive FDA 510(k) clearance?
OLYMPUS URF-P6/P6R received FDA 510(k) clearance on 2018-03-29, under 510(k) number K172298.
Who is the listed applicant for OLYMPUS URF-P6/P6R?
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-P6/P6R?
The FDA product code for OLYMPUS URF-P6/P6R 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.