K230551 is an FDA 510(k) clearance for the Visual-ICE Cryoablation System. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on August 8, 2023, 161 days after receiving the submission on February 28, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K230551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2023 |
| Decision Date | August 08, 2023 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |