C2 Therapeutics, Inc.: FDA clearances and approvals
C2 Therapeutics, Inc. has 10 FDA 510(k) clearances (first 2010, latest 2018), across 3 product codes in 2 review panels. Median 510(k) review time: 88 days. openFDA lists 1 product recall by a recalling firm named C2 Therapeutics, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 86 |
| 2014 | 0 | — |
| 2015 | 3 | 78 |
| 2016 | 3 | 41 |
| 2017 | 1 | 252 |
| 2018 | 1 | 391 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, C2 Therapeutics, Inc.'s cleared 510(k)s took a median 322 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 8 | 8 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Review panels
Most recent C2 Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163684 | C2 CryoBalloon Ablation System | GEH | 2018-01-23 | 391 |
| K161202 | C2 Cryoballoon Ablation System | GEH | 2017-01-05 | 252 |
| K160994 | C2 CryoBalloon Focal Pear Catheter | GEH | 2016-05-19 | 41 |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | GEH | 2016-04-13 | 239 |
| K153541 | Coldplay CryoBalloon® Ablation System | GEH | 2016-01-07 | 28 |
| K152140 | Boa Endoscopic Valve | OCX | 2015-10-13 | 71 |
| K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System | GEH | 2015-07-07 | 78 |
| K150083 | Sidecar External Working Channel | FED | 2015-04-14 | 89 |
| K131523 | CRYOBALLOON FOCAL ABLATION SYSTEM | GEH | 2013-08-22 | 86 |
| K101825 | CRYOBALLOON ABLATION SYSTEM | GEH | 2010-09-29 | 90 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-01-06.
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 C2 Therapeutics, Inc. have?
C2 Therapeutics, Inc. has 10 FDA 510(k) clearances (first 2010, latest 2018), across 3 product codes in 2 review panels.
How long does FDA take to clear C2 Therapeutics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across C2 Therapeutics, Inc.'s cleared 510(k)s is 88 days.
What devices does C2 Therapeutics, Inc. make?
Its most frequent FDA product codes are GEH (Unit, Cryosurgical, Accessories, 8); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 1); OCX (Endoscopic Irrigation/Suction System, 1).
Has C2 Therapeutics, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches C2 Therapeutics, Inc; the most recent began 2017-01-06. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 C2 Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, C2 Therapeutics, 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.