FDA 510(k) Applications Submitted by Avanos Medical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K203066 |
10/09/2020 |
COOLIEF Cooled Radiofrequency Kit Advanced |
Avanos Medical, Inc. |
| K243572 |
11/18/2024 |
Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game R |
Avanos Medical, Inc. |
| K240965 |
04/09/2024 |
CORTRAK* 2 Enteral Access System (20-0950) |
Avanos Medical, Inc. |
| K241185 |
04/29/2024 |
CORGRIP* SR NG/NI Tube Retention System |
Avanos Medical, Inc. |
| K242057 |
07/15/2024 |
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) |
Avanos Medical, Inc. |
| K191340 |
05/20/2019 |
CORTRAK* 2 Equilateral Enteral Access System |
Avanos Medical, Inc. |
| K192491 |
09/11/2019 |
Coolief Radiofrequency Generator (CRG) System |
Avanos Medical, Inc. |
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