K232635 is an FDA 510(k) clearance for the IceSeed 1.5 CX 90º Needle (H7493967433170). This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on November 22, 2023, 84 days after receiving the submission on August 30, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K232635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2023 |
| Decision Date | November 22, 2023 |
| Days to Decision | 84 days |
| Submission Type | Special |
| 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 |