K190651 is an FDA 510(k) clearance for the ERBECRYO 2 Cryosurgical Unit. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Erbe Elektromedizin GmbH (Tuebingen, DE). The FDA issued a Cleared decision on January 7, 2020, 300 days after receiving the submission on March 13, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K190651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2019 |
| Decision Date | January 07, 2020 |
| Days to Decision | 300 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 |