K181864 is an FDA 510(k) clearance for the Polaris RF Ablation System. This device is classified as a Generator, Lesion, Radiofrequency (Class II - Special Controls, product code GXD).
Submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on January 2, 2019, 174 days after receiving the submission on July 12, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4400.
| 510(k) Number | K181864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2018 |
| Decision Date | January 02, 2019 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXD — Generator, Lesion, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4400 |