Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002647932

FEI Number

3002647932

Entity Name

Uroplasty, LLC

City/State/Country

Minnetonka, MN, US

Establishment Address

5420 FELTL ROAD, Minnetonka, MN 55343, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Uroplasty, LLC (Owner Number: 9077485)

Owner / Operator Contact Address

5420 FELTL RD., --, Minnetonka, MN 55343, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VOX Implants MACROPLASTIQUE IMPLANTS Rigid Endoscopic Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MIX	System, Vocal Cord Medialization	Ear, Nose, Throat	Class 2	874.3620	2007-11-21
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown	Class 3	N/A	2007-07-10
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2012-12-19
FHR	Needle, Gastro-Urology	General, Plastic Surgery	Class 1	878.4800	2018-02-26

Official Correspondent

Nicole Boser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Uroplasty, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-06	Boston Scientific Corporation	3	Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002647932. Last updated year: 2026. Please use registration number 3002647932 when referencing this establishment in official correspondence.