Celonova Biosciences, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Celonova Biosciences, Inc.” (first 2008, latest 2014), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 | 0 | — |
| 2013 | 2 | 30 |
| 2014 | 2 | 97 |
| 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 |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | 4 | 4 |
| MAF | Stent, Coronary | 1 | 0 |
| NAJ | Agents, Embolic, For Treatment Of Uterine Fibroids | 1 | 1 |
Review panels
Most recent Celonova Biosciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141209 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES | KRD | 2014-08-07 | 90 |
| K133447 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES | NAJ | 2014-02-24 | 104 |
| K132675 | EMBOZENE MICROSPHERES | KRD | 2013-10-03 | 36 |
| K130307 | ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE | KRD | 2013-03-04 | 25 |
| K073417 | EMBOZENE MICROSPHERES | KRD | 2008-12-15 | 377 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160014 | PMA | COBRA PzF NanoCoated Coronary Stent System | 2017-02-21 |
Recalls
openFDA lists no recalls under a recalling firm named Celonova Biosciences, 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 Celonova Biosciences, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03103620: Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry (Completed, started 2015-09-10)
- NCT01925794: COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT (Completed, started 2013-08-21)
- NCT00799344: REVEAL Study: Vessel Healing After Angioplasty (Completed, started 2008-06)
- NCT00799032: The ATLANTA First in Man Study of the Catania Stent (Completed, started 2007-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Celonova Biosciences, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Celonova Biosciences, Inc.” (first 2008, latest 2014), plus 1 PMA decision, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Celonova Biosciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Celonova Biosciences, Inc. is 90 days.
Which FDA product codes appear under Celonova Biosciences, Inc.?
The most frequent FDA product codes under this applicant name are KRD (Device, Vascular, For Promoting Embolization, 4); MAF (Stent, Coronary, 1); NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids, 1).
Next steps
- See all 5 Celonova Biosciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KRD, Celonova Biosciences, 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.