Medical Device Manufacturer · CN , Xiangtan

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

17 submissions · 17 cleared · Since 2020
17
Total
17
Cleared
0
Denied

Hunan Vathin Medical Instrument Co., Ltd. has 17 FDA 510(k) cleared medical devices. Based in Xiangtan, CN.

Latest FDA clearance: Jul 2025. Active since 2020. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Hunan Vathin Medical Instrument Co., Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Guangzhou Osmunda Medical Device Technical Service Co., Ltd. as regulatory consultant.

FDA 510(k) Regulatory Record - Hunan Vathin Medical Instrument Co., Ltd.
17 devices
1-17 of 17
Cleared Jul 25, 2025
Vathin® Video Bronchoscope System
K250232 · EOQ
Ear, Nose, Throat · 179d
Cleared Jul 03, 2025
Single-use Ureteral Access Sheath
K251599 · FED
Gastroenterology & Urology · 37d
Cleared May 06, 2025
Single-use Flexible Ureteroscope
K250785 · FGB
Gastroenterology & Urology · 53d
Cleared Jan 29, 2025
Digital Video Processor
K243117 · FGB
Gastroenterology & Urology · 121d
Cleared Jan 16, 2025
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10,...
K242416 · EOQ
Ear, Nose, Throat · 154d
Cleared Dec 18, 2024
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R,...
K242535 · FAJ
Gastroenterology & Urology · 114d
Cleared Oct 29, 2024
Video Bronchoscope System
K241612 · EOQ
Ear, Nose, Throat · 146d
Cleared Oct 08, 2024
Single-use Ureteral Access Sheath
K240167 · FED
Gastroenterology & Urology · 260d
Cleared Oct 04, 2024
Video Ureteroscope System
K241434 · FGB
Gastroenterology & Urology · 136d
Cleared Jan 17, 2024
Video Ureteroscope System
K231135 · FGB
Gastroenterology & Urology · 271d
Cleared Jun 14, 2023
Single-use Flexible Rhinolaryngoscope
K230536 · EOB
Ear, Nose, Throat · 107d
Cleared May 18, 2023
Single-Use Flexible Ureteroscope
K230200 · FGB
Gastroenterology & Urology · 113d
Cleared May 15, 2023
Vathin® Video Bronchoscope System
K223836 · EOQ
Ear, Nose, Throat · 144d
Cleared Nov 18, 2022
Single-Use Flexible Cystoscope
K221580 · FAJ
Gastroenterology & Urology · 170d
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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