FDA.reportPublic FDA data

UROCURE, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30138598373013859837UROCURE, LLC1N2026-01-011856 Corporate Dr Ste 135 Norcross GA US 30093

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2321001749290802K222468ArcTO Transobturator Sling SystemOTN2022-09-15
2321001196751849K222293ArcSP Suprapubic Sling SystemOTN2022-09-21
2321001725238424K183134ArcTV Transvaginal Sling SystemOTN2019-02-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OTN32022-09-21