Hunan Vathin Medical Instrument Co., Ltd.
Xiangtan Hunan, CN
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. appears in FDA device records in Xiangtan Hunan, CN. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Hunan Vathin Medical Instrument Co., Ltd. between 2020 and 2025. The busiest year on record is 2024, with 5. The most recent is 2025, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 5 |
| 2025 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250232 | Vathin® Video Bronchoscope System | EOQ | Substantially Equivalent | |
| K251599 | Single-use Ureteral Access Sheath | FED | Substantially Equivalent | |
| K250785 | Single-use Flexible Ureteroscope | FGB | Substantially Equivalent | |
| K243117 | Digital Video Processor | FGB | Substantially Equivalent | |
| 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 | |
| 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 | |
| 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 | |
| K240167 | Single-use Ureteral Access Sheath | FED | Substantially Equivalent | |
| K241434 | Video Ureteroscope System | FGB | Substantially Equivalent | |
| K231135 | Video Ureteroscope System | FGB | Substantially Equivalent | |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | EOB | Substantially Equivalent | |
| K230200 | Single-Use Flexible Ureteroscope | FGB | Substantially Equivalent | |
| K223836 | Vathin® Video Bronchoscope System | EOQ | Substantially Equivalent | |
| K221581 | Single-Use Flexible Rhinolaryngoscope | EOB | Substantially Equivalent | |
| K221580 | Single-Use Flexible Cystoscope | FAJ | Substantially Equivalent | |
| K213635 | Vathin Video Bronchoscope System | EOQ | Substantially Equivalent | |
| K191828 | Vathin Video Bronchoscope System | EOQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016045249 | 3016045249 | HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. | 1/F, Building 12, Innovation and Entrepreneurship Service Center, No.9 Chuanqi West road, Xiangtan Hunan 411100 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain