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Hunan Vathin Medical Instrument Co., Ltd.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories5
Latest FDA decision2025-07-25
TypeNumberDevice NameCodeDateActions
510(k) K250232 Vathin® Video Bronchoscope SystemEOQ2025-07-25 View
510(k) K251599 Single-use Ureteral Access SheathFED2025-07-03 View
510(k) K250785 Single-use Flexible UreteroscopeFGB2025-05-06 View
510(k) K243117 Digital Video ProcessorFGB2025-01-29 View
510(k) 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-50mLEOQ2025-01-16 View
510(k) 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)FAJ2024-12-18 View
510(k) 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)EOQ2024-10-29 View
510(k) K240167 Single-use Ureteral Access SheathFED2024-10-08 View
510(k) K241434 Video Ureteroscope SystemFGB2024-10-04 View
510(k) K231135 Video Ureteroscope SystemFGB2024-01-17 View
510(k) K230536 Single-use Flexible Rhinolaryngoscope; Digital Video MonitorEOB2023-06-14 View
510(k) K230200 Single-Use Flexible UreteroscopeFGB2023-05-18 View
510(k) K223836 Vathin® Video Bronchoscope SystemEOQ2023-05-15 View
510(k) K221581 Single-Use Flexible RhinolaryngoscopeEOB2022-11-18 View
510(k) K221580 Single-Use Flexible CystoscopeFAJ2022-11-18 View
510(k) K213635 Vathin Video Bronchoscope SystemEOQ2022-02-28 View
510(k) K191828 Vathin Video Bronchoscope SystemEOQ2020-02-13 View
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