K203024 is an FDA 510(k) clearance for the C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Pentax of America, Inc. (Redwood, Ca, US). The FDA issued a Cleared decision on November 24, 2020, 53 days after receiving the submission on October 2, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K203024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2020 |
| Decision Date | November 24, 2020 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |