510(k) K131523 ยท GEH Unit, Cryosurgical, Accessories
CRYOBALLOON FOCAL ABLATION SYSTEM
| Applicant | C2 Therapeutics, Redwood, Ca CA, US |
| Decision | Substantially Equivalent, Aug 22, 2013 |
| Received | May 28, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131523
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2018 | PENTAX of America Inc C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications. Terminated |
GEH | None listed |
| Mar 15, 2017 | C2 Therapeutics, Inc. C2 CryoBalloon Ablation System - Controller Cap.
C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device
The affected product is the Controller Cap component only, which is provided to Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.