ArcTV Transvaginal Sling System
K-Number: K183134 · 2019-02-07
ApplicantUrocure, LLC
Decision Date2019-02-07
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ArcTV Transvaginal Sling System is a medical device manufactured by Urocure, LLC. It received FDA 510(k) clearance on 2019-02-07 under approval number K183134. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ArcTV Transvaginal Sling System?
ArcTV Transvaginal Sling System is a medical device that received FDA 510(k) clearance on 2019-02-07. It is manufactured by Urocure, LLC. The 510(k) number is K183134.
When was ArcTV Transvaginal Sling System approved by the FDA?
ArcTV Transvaginal Sling System received FDA 510(k) clearance on 2019-02-07, under approval number K183134.
What company makes ArcTV Transvaginal Sling System?
ArcTV Transvaginal Sling System is manufactured by Urocure, LLC.
What is the FDA product code for ArcTV Transvaginal Sling System?
The FDA product code for ArcTV Transvaginal Sling System is OTN.
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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.