Data / Medical devices / United States / Uroplasty, LLC

Uroplasty, LLC: FDA-registered device maker in Minnetonka, MN, United States, 3 510(k) clearances and 2 PMA approvals

Name: Uroplasty, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Uroplasty, LLC is registered with the FDA (registration 3002647932) in Minnetonka, MN, United States. It lists 8 device types. The FDA files 3 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 3, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002647932
Address: 5420 Feltl Road, Minnetonka, MN, United States, 55343
Owner or operator: Uroplasty, LLC (9077485)
Roles: Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: July 10, 2007
Registered through: 2026
Brand names listed: Administration Device, MACROPLASTIQUE IMPLANTS, Optilume Basic Urological Balloon Dilation Catheter with Basic Balloon Kit, Optilume® Urethral Drug Coated Balloon Kit, Rigid Endoscopic Needle, Urgent PC Neuromodulation System, VOX Implants

Devices it lists

Device	Product code	Class	Role	Source
Agent, Bulking, Injectable For Gastro-Urology Use	LNM	3	Manufacturer	accessdata.fda.gov
Catheter, Balloon, Urethral, Drug-Coated	QRH	3	Repackager or relabeler	accessdata.fda.gov
Dilator, Urethral	KOE	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Manufacturer, Specification developer	accessdata.fda.gov
Needle, Gastro-Urology	FHR	1	Specification developer	accessdata.fda.gov
Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence	NAM	2	Manufacturer, Specification developer	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Manufacturer	accessdata.fda.gov
System, Vocal Cord Medialization	MIX	2	Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 2, 2020	K191061	Optilume Basic Urological Balloon Dilation Catheter	KOE	Substantially Equivalent	Urotronic, Inc.	accessdata.fda.gov
August 3, 2012	K121337	UROPLASTY RIGID ENDOSCPIC NEEDLES	FBK	Substantially Equivalent	Uroplasty, Inc.	accessdata.fda.gov
October 21, 2010	K101847	URGENT PC STIMULATOR; URGENT PC LEAD SET	NAM	Substantially Equivalent	Uroplasty, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 3, 2021	P210020	Optilume Urethral Drug Coated Balloon	QRH	9	June 23, 2025	accessdata.fda.gov
October 30, 2006	P040050	MACROPLASTIQUE IMPLANTS	LNM	11	May 9, 2023	accessdata.fda.gov

Compare with other makers

Updated June 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.