The following data is part of a premarket notification filed by Avanos Medical, Inc. with the FDA for Coolief Cooled Radiofrequency Kit Advanced.
| Device ID | K203066 |
| 510k Number | K203066 |
| Device Name: | COOLIEF Cooled Radiofrequency Kit Advanced |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Avanos Medical, Inc. 5405 Windward Parkway, Suite 100 Alpharetta, GA 30004 |
| Contact | Christian Supina |
| Correspondent | Rafael Aguila Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, FL 33155 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-10-09 |
| Decision Date | 2020-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193493479839 | K203066 | 000 |
| 10193493478870 | K203066 | 000 |
| 10193493478863 | K203066 | 000 |
| 10193493478856 | K203066 | 000 |
| 10193493478849 | K203066 | 000 |
| 10193493478832 | K203066 | 000 |
| 10193493478825 | K203066 | 000 |
| 10193493478818 | K203066 | 000 |
| 10193493478801 | K203066 | 000 |
| 10193493000200 | K203066 | 000 |
| 10193493000194 | K203066 | 000 |
| 10193493000170 | K203066 | 000 |
| 10193493000163 | K203066 | 000 |
| 10193493478887 | K203066 | 000 |
| 10193493478894 | K203066 | 000 |
| 10193493479082 | K203066 | 000 |
| 10193493479075 | K203066 | 000 |
| 10193493479068 | K203066 | 000 |
| 10193493479051 | K203066 | 000 |
| 10193493479044 | K203066 | 000 |
| 10193493479037 | K203066 | 000 |
| 10193493479020 | K203066 | 000 |
| 10193493479006 | K203066 | 000 |
| 10193493478986 | K203066 | 000 |
| 10193493478924 | K203066 | 000 |
| 10193493478917 | K203066 | 000 |
| 10193493478900 | K203066 | 000 |
| 10193493000156 | K203066 | 000 |