Advanced Uroscience, Inc.: FDA clearances and approvals
Advanced Uroscience, Inc. has 5 FDA 510(k) clearances (first 1998, latest 2001), across 3 product codes in 2 review panels. Median 510(k) review time: 70 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 3 | 3 |
| GDW | Staple, Implantable | 1 | 1 |
| PAG | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 1 | 1 |
Review panels
Most recent Advanced Uroscience, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001807 | TISSUE MARKER | GDW | 2001-05-03 | 322 |
| K002573 | ADVANCED UROSCIENCE INNERSHEATH | FBK | 2000-11-16 | 90 |
| K002323 | ADVANCED UROSCIENCE INJECTION NEEDLE | FBK | 2000-07-31 | 34 |
| K993459 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | PAG | 1999-11-05 | 23 |
| K982890 | ADVANCED UROSCIENCE INJECTION NEEDLE | FBK | 1998-10-26 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Uroscience, 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.
Frequently asked questions
How many FDA 510(k) clearances does Advanced Uroscience, Inc. have?
Advanced Uroscience, Inc. has 5 FDA 510(k) clearances (first 1998, latest 2001), across 3 product codes in 2 review panels.
How long does FDA take to clear Advanced Uroscience, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Uroscience, Inc.'s cleared 510(k)s is 70 days.
What devices does Advanced Uroscience, Inc. make?
Its most frequent FDA product codes are FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 3); GDW (Staple, Implantable, 1); PAG (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, 1).
Has Advanced Uroscience, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Uroscience, Inc. Related entities may recall under other names.
Next steps
- See all 5 Advanced Uroscience, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FBK, Advanced Uroscience, 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.