Uroplasty, Inc.: FDA clearances and approvals
Uroplasty, Inc. has 8 FDA 510(k) clearances (first 2005, latest 2012), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time: 60 days. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Uroplasty, Inc. is the industry 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 does Uroplasty, Inc. have?
Uroplasty, Inc. has 8 FDA 510(k) clearances (first 2005, latest 2012), plus 1 PMA decision, across 4 product codes in 1 review panel.
How long does FDA take to clear Uroplasty, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Uroplasty, Inc.'s cleared 510(k)s is 60 days.
What devices does Uroplasty, Inc. make?
Its most frequent FDA product codes 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).
Has Uroplasty, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Uroplasty, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.