The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Coolief* Cooled Rf Probe.
| Device ID | K163461 |
| 510k Number | K163461 |
| Device Name: | Coolief* Cooled RF Probe |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Halyard Health, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Monica King |
| Correspondent | Monica King Halyard Health, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-09 |
| Decision Date | 2017-04-13 |
| Summary: | summary |