Uroplasty, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Uroplasty, Inc.” (first 2005, latest 2012), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 92 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NAM | Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | 4 | 4 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 3 | 3 |
| LNM | Agent, Bulking, Injectable For Gastro-Urology Use | 1 | 0 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 1 | 1 |
Review panels
Most recent Uroplasty, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121337 | UROPLASTY RIGID ENDOSCPIC NEEDLES | FBK | 2012-08-03 | 92 |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | NAM | 2010-10-21 | 112 |
| K091391 | UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 | FBK | 2009-06-30 | 50 |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | NAM | 2007-08-20 | 48 |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | NAM | 2006-07-03 | 52 |
| K052175 | I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 | OTN | 2005-10-17 | 68 |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | NAM | 2005-10-17 | 82 |
| K051905 | UROPLASTY RIGID ENDOSCOPIC NEEDLE | FBK | 2005-08-29 | 46 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040050 | PMA | MACROPLASTIQUE IMPLANTS | 2006-10-30 |
Recalls
openFDA lists no recalls under a recalling firm named Uroplasty, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Uroplasty, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00928395: Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms (Completed, started 2009-01)
- NCT00771264: Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms (Completed, started 2008-09)
- NCT00448175: Overactive Bladder Innovative Therapy Trial (OrBIT) (Completed, started 2006-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Uroplasty, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Uroplasty, Inc.” (first 2005, latest 2012), plus 1 PMA decision, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Uroplasty, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Uroplasty, Inc. is 60 days.
Which FDA product codes appear under Uroplasty, Inc.?
The most frequent FDA product codes under this applicant name are NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence, 4); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 3); LNM (Agent, Bulking, Injectable For Gastro-Urology Use, 1).
Next steps
- See all 8 Uroplasty, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NAM, Uroplasty, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.