Trans-anal Introducer
K-Number: K171208 · 2018-02-05
ApplicantVisionsense, Ltd.
Decision Date2018-02-05
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Trans-anal Introducer is a medical device manufactured by Visionsense, Ltd.. It received FDA 510(k) clearance on 2018-02-05 under approval number K171208. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Trans-anal Introducer?
Trans-anal Introducer is a medical device that received FDA 510(k) clearance on 2018-02-05. It is manufactured by Visionsense, Ltd.. The 510(k) number is K171208.
When was Trans-anal Introducer approved by the FDA?
Trans-anal Introducer received FDA 510(k) clearance on 2018-02-05, under approval number K171208.
What company makes Trans-anal Introducer?
Trans-anal Introducer is manufactured by Visionsense, Ltd..
What is the FDA product code for Trans-anal Introducer?
The FDA product code for Trans-anal Introducer is FED.
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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.