Uroview FD II
K-Number: K180651 · 2018-04-12
ApplicantPausch Medical GmbH
Decision Date2018-04-12
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Uroview FD II is a medical device manufactured by Pausch Medical GmbH. It received FDA 510(k) clearance on 2018-04-12 under approval number K180651. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Uroview FD II?
Uroview FD II is a medical device that received FDA 510(k) clearance on 2018-04-12. It is manufactured by Pausch Medical GmbH. The 510(k) number is K180651.
When was Uroview FD II approved by the FDA?
Uroview FD II received FDA 510(k) clearance on 2018-04-12, under approval number K180651.
What company makes Uroview FD II?
Uroview FD II is manufactured by Pausch Medical GmbH.
What is the FDA product code for Uroview FD II?
The FDA product code for Uroview FD II is JAA.
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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.