ArcTO Transobturator Sling System
K-Number: K222468 · 2022-09-15
ApplicantUrocure, LLC
Decision Date2022-09-15
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ArcTO Transobturator Sling System is a medical device manufactured by Urocure, LLC. It received FDA 510(k) clearance on 2022-09-15 under approval number K222468. 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 ArcTO Transobturator Sling System?
ArcTO Transobturator Sling System is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by Urocure, LLC. The 510(k) number is K222468.
When was ArcTO Transobturator Sling System approved by the FDA?
ArcTO Transobturator Sling System received FDA 510(k) clearance on 2022-09-15, under approval number K222468.
What company makes ArcTO Transobturator Sling System?
ArcTO Transobturator Sling System is manufactured by Urocure, LLC.
What is the FDA product code for ArcTO Transobturator Sling System?
The FDA product code for ArcTO Transobturator 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.