Medical Device Manufacturer · CN , Xiangtan

Hunan Vathin Medical Instrument Co., Ltd.

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

Hunan Vathin Medical Instrument Co., Ltd. — FDA 510(k) Submissions

Hunan Vathin Medical Instrument Co., Ltd. has submitted 17 FDA 510(k) premarket notifications since 2020, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bronchoscope (flexible Or Rigid), Ureteroscope And Accessories, Flexible/rigid, Endoscopic Access Overtube, Gastroenterology-urology, Cystoscope And Accessories, Flexible/rigid, Nasopharyngoscope (flexible Or Rigid) . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
Vathin? Video Bronchoscope System
K250232 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Jul 2025 179d
Single-use Ureteral Access Sheath
K251599 · FED Endoscopic Access... · Gastroenterology & Urology
Jul 2025 37d
Single-use Flexible Ureteroscope
K250785 · FGB Ureteroscope And... · Gastroenterology & Urology
May 2025 53d
Digital Video Processor
K243117 · FGB Ureteroscope And... · Gastroenterology & Urology
Jan 2025 121d
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL
K242416 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Jan 2025 154d
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)
K242535 · FAJ Cystoscope And... · Gastroenterology & Urology
Dec 2024 114d
Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
K241612 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Oct 2024 146d
Single-use Ureteral Access Sheath
K240167 · FED Endoscopic Access... · Gastroenterology & Urology
Oct 2024 260d
Video Ureteroscope System
K241434 · FGB Ureteroscope And... · Gastroenterology & Urology
Oct 2024 136d
Video Ureteroscope System
K231135 · FGB Ureteroscope And... · Gastroenterology & Urology
Jan 2024 271d
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
K230536 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Jun 2023 107d
Single-Use Flexible Ureteroscope
K230200 · FGB Ureteroscope And... · Gastroenterology & Urology
May 2023 113d
Vathin? Video Bronchoscope System
K223836 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
May 2023 144d
Single-Use Flexible Cystoscope
K221580 · FAJ Cystoscope And... · Gastroenterology & Urology
Nov 2022 170d
Single-Use Flexible Rhinolaryngoscope
K221581 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Nov 2022 170d
Vathin Video Bronchoscope System
K213635 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Feb 2022 103d
Vathin Video Bronchoscope System
K191828 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Feb 2020 220d
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