Decision Date2022-09-02
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Visera Hysterovideoscope Olympus HYF Type V is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K221557. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Visera Hysterovideoscope Olympus HYF Type V?
Visera Hysterovideoscope Olympus HYF Type V is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K221557.
When did Visera Hysterovideoscope Olympus HYF Type V receive FDA 510(k) clearance?
Visera Hysterovideoscope Olympus HYF Type V received FDA 510(k) clearance on 2022-09-02, under 510(k) number K221557.
Who is the listed applicant for Visera Hysterovideoscope Olympus HYF Type V?
The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Visera Hysterovideoscope Olympus HYF Type V?
The FDA product code for Visera Hysterovideoscope Olympus HYF Type V is HIH.
Other records listing Olympus Medical Systems Corporation 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.