Uroplasty, LLC
Minnetonka, MN, US
Uroplasty, LLC appears in FDA device records in Minnetonka, MN. FDA records list 8 510(k) clearances between and , 12 PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Uroplasty, LLC between 2005 and 2012. The busiest year on record is 2005, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121337 | UROPLASTY RIGID ENDOSCPIC NEEDLES | FBK | Substantially Equivalent | |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | NAM | Substantially Equivalent | |
| K091391 | UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 | FBK | Substantially Equivalent | |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | NAM | Substantially Equivalent | |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | NAM | Substantially Equivalent | |
| K052175 | I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 | OTN | Substantially Equivalent | |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | NAM | Substantially Equivalent | |
| K051905 | UROPLASTY RIGID ENDOSCOPIC NEEDLE | FBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002647932 | 3002647932 | Uroplasty, LLC | 5420 FELTL ROAD, Minnetonka, MN 55343 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LNMAgent, Bulking, Injectable For Gastro-Urology Use
- QRHCatheter, Balloon, Urethral, Drug-Coated
- KOEDilator, Urethral
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- FHRNeedle, Gastro-Urology
- NAMStimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
- KOASurgical Instruments, G-U, Manual (And Accessories)
- MIXSystem, Vocal Cord Medialization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Uroplasty, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain