Medical Device Manufacturer · CN , Xiangtan

Hunan Vathin Medical Instrument Co., Ltd. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2020

Recent clearances: Vathin® Video Bronchoscope System, Single-use Ureteral Access Sheath, Single-use Flexible Ureteroscope

17
Total
17
Cleared
0
Denied

FDA 510(k) Regulatory Record - Hunan Vathin Medical Instrument Co., Ltd. Ear, Nose, Throat ✕

8 devices
1-8 of 8
Cleared Jul 25, 2025
Vathin® Video Bronchoscope System
K250232 · EOQ
Ear, Nose, Throat · 179d
Cleared Jan 16, 2025
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10,...
K242416 · EOQ
Ear, Nose, Throat · 154d
Cleared Oct 29, 2024
Video Bronchoscope System
K241612 · EOQ
Ear, Nose, Throat · 146d
Cleared Jun 14, 2023
Single-use Flexible Rhinolaryngoscope
K230536 · EOB
Ear, Nose, Throat · 107d
Cleared May 15, 2023
Vathin® Video Bronchoscope System
K223836 · EOQ
Ear, Nose, Throat · 144d
Cleared Nov 18, 2022
Single-Use Flexible Rhinolaryngoscope
K221581 · EOB
Ear, Nose, Throat · 170d
Cleared Feb 28, 2022
Vathin Video Bronchoscope System
K213635 · EOQ
Ear, Nose, Throat · 103d
Cleared Feb 13, 2020
Vathin Video Bronchoscope System
K191828 · EOQ
Ear, Nose, Throat · 220d
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