Pelvalon, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Pelvalon, Inc.” (first 2015, latest 2015), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 253 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 |
|---|---|---|
| 2015 | 1 | 253 |
| 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 |
|---|---|---|---|
| PJH | Dynamic Rectal Control System | 2 | 1 |
Review panels
Most recent Pelvalon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150558 | Eclipse System | PJH | 2015-11-12 | 253 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140020 | De Novo | Dynamic Rectal Control System | 2015-02-12 |
Recalls
openFDA lists no recalls under a recalling firm named Pelvalon, 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 Pelvalon, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03028636: LIBERATE - PRO: Eclipse™ System Registry (Completed, started 2016-09-19)
- NCT02428595: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women (Completed, started 2015-05-15)
- NCT01655498: A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE) (Completed, started 2012-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pelvalon, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Pelvalon, Inc.” (first 2015, latest 2015), plus 1 De Novo decision, across 1 product code 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 Pelvalon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pelvalon, Inc. is 253 days.
Which FDA product codes appear under Pelvalon, Inc.?
The most frequent FDA product codes under this applicant name are PJH (Dynamic Rectal Control System, 2).
Next steps
- See all 1 Pelvalon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PJH, Pelvalon, 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.