FDA.reportPublic FDA data

Uroplasty, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30026479323002647932Uroplasty, LLC1N2026-01-015420 FELTL ROAD Minnetonka MN US 55343

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08717591240167Urgent® PC Neuromodulation System - Lead Set866-258-2182info.usa@cogentixmedical.com
08717591240228Urgent® PC Neuromodulation System - Stimulator866-258-2182info.usa@cogentixmedical.com
08717591240273Rigid Endoscopic Needle - MRN-518866-258-2182info.usa@cogentixmedical.com
08717591240280Rigid Endoscopic Needle - MRN-420866-258-2182info.usa@cogentixmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
657071129114684P210020Optilume Urethral Drug Coated BalloonQRH2021-12-03
657071349610773P040050MACROPLASTIQUE IMPLANTSLNM2006-10-30
657072071940817K191061Optilume Basic Urological Balloon Dilation CatheterKOE2020-01-02
657071234529947K121337UROPLASTY RIGID ENDOSCPIC NEEDLESFBK2012-08-03
657071428567998K101847URGENT PC STIMULATOR; URGENT PC LEAD SETNAM2010-10-21
657071156437589
657071570162222
657071812839962
657071397115275
657071592795713
657071640257543

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QRH 12021-12-03
KOE12020-01-02
FBK12012-08-03
NAM12010-10-21
LNM12006-10-30

PMA#

PMN#

GUDID#