Medical Device Manufacturer · US , Alpharetta , GA

Avanos Medical, Inc.

8 submissions · 8 cleared · Since 2019
8
Total
8
Cleared
0
Denied

Avanos Medical, Inc. — FDA 510(k) Submissions

Avanos Medical, Inc. has submitted 8 FDA 510(k) premarket notifications since 2019, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tubes, Gastrointestinal (and Accessories), Generator, Lesion, Radiofrequency, Probe, Radiofrequency Lesion, Massager, Powered Inflatable Tube . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
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 Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
K243572 · IRP Massager, Powered... · Physical Medicine
Jan 2025 74d
CORGRIP* SR NG/NI Tube Retention System
K241185 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Oct 2024 179d
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
K242057 · GXD Generator, Lesion,... · Neurology
Aug 2024 30d
CORTRAK* 2 Enteral Access System (20-0950)
K240965 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jun 2024 58d
Avanos* CORTRAK* 2 Enteral Access System (EAS)
K220588 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Apr 2022 52d
COOLIEF Cooled Radiofrequency Kit Advanced
K203066 · GXI Probe, Radiofrequency Lesion · Neurology
Dec 2020 74d
Coolief Radiofrequency Generator (CRG) System
K192491 · GXD Generator, Lesion,... · Neurology
Feb 2020 163d
CORTRAK* 2 Equilateral Enteral Access System
K191340 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jun 2019 15d
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