Data / Medical devices / China / Hunan Vathin Medical Instrument Co., Ltd.
Hunan Vathin Medical Instrument Co., Ltd.: FDA-registered device maker in Xiangtan Hunan, China, 17 510(k) clearances
Hunan Vathin Medical Instrument Co., Ltd. is registered with the FDA (registration 3016045249) in Xiangtan Hunan, China. It lists 6 device types. The FDA files 17 510(k) clearances under its listings, the newest dated July 25, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3016045249
- Address
- 1/F, Building 12, Innovation and Entrepreneurship Service Center, No.9 Chuanqi West road Jiuhua Economic Development Zone, Xiangtan Hunan, China, 411100
- Owner or operator
- Hunan Vathin Medical Instrument Co., Ltd. (10062555)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 18, 2020
- Registered through
- 2027
- Brand names listed
- Digital Video Monitor, Digital Video Monitor, DVM-B1, Digital Video Processor, Digital Video Processor (SYS-5100), Pylon , ST-A1,MP-A1,MP-A2,MP-A3, Single-Use Flexible Rhinolaryngoscope, Single-Use Ureteral Access Sheath, Single-use Flexible Bronchoscope and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | 1 | Manufacturer | accessdata.fda.gov |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2025 | K250232 | Vathin® Video Bronchoscope System | EOQ | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| July 3, 2025 | K251599 | Single-use Ureteral Access Sheath | FED | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| May 6, 2025 | K250785 | Single-use Flexible Ureteroscope | FGB | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| January 29, 2025 | K243117 | Digital Video Processor | FGB | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| January 16, 2025 | K242416 | 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 | EOQ | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| December 18, 2024 | K242535 | 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) | FAJ | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 29, 2024 | K241612 | 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) | EOQ | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 8, 2024 | K240167 | Single-use Ureteral Access Sheath | FED | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 4, 2024 | K241434 | Video Ureteroscope System | FGB | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| June 14, 2023 | K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | EOB | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| May 18, 2023 | K230200 | Single-Use Flexible Ureteroscope | FGB | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| May 15, 2023 | K223836 | Vathin® Video Bronchoscope System | EOQ | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 18, 2022 | K221581 | Single-Use Flexible Rhinolaryngoscope | EOB | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 18, 2022 | K221580 | Single-Use Flexible Cystoscope | FAJ | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| February 28, 2022 | K213635 | Vathin Video Bronchoscope System | EOQ | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
| February 19, 2021 | K202346 | SPiN Vision Video Bronchoscope System | EOQ | Substantially Equivalent | Veran Medical Technologies, Inc. | accessdata.fda.gov |
| February 13, 2020 | K191828 | Vathin Video Bronchoscope System | EOQ | Substantially Equivalent | Hunan Vathin Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Nasopharyngoscope (Flexible Or Rigid)
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Accessories, Photographic, For Endoscope (Exclude Light Sources)
Updated July 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.