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Ga Health Company Limited

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories4
Latest FDA decision2023-10-16
TypeNumberDevice NameCodeDateActions
510(k) K232118 ANDORATE® Valve KitODC2023-10-16 View
510(k) K231602 Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingOCX2023-08-01 View
510(k) K230932 ANDORATE® Valve KitOCX2023-07-07 View
510(k) K230280 ANDORATE® Suction Valve and ANDORATE® Biopsy ValveKTI2023-05-11 View
510(k) K223171 AquaPulse® Irrigation TubingOCX2022-11-10 View
510(k) K213095 andorate Suction Valve, andorate Air/Water ValveODC2022-01-12 View
510(k) K202838 Andorate Universal Endoscope Tip GuardOCU2021-03-05 View
510(k) K202560 AquaPulse Irrigation TubingOCX2020-12-10 View
510(k) K200495 Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveODC2020-06-24 View
510(k) K200481 Andorate Biopsy Valve, Andorate Biopsy IrrigatorODC2020-06-18 View
510(k) K200479 AquaPulse Auxiliary Water ConnectorOCX2020-05-15 View
510(k) K200388 Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ConnectorOCX2020-04-14 View