FDA 510(k) Applications Submitted by Cindy Ye

FDA 510(k) Number Submission Date Device Name Applicant
K230280 02/01/2023 ANDORATE« Suction Valve and ANDORATE« Biopsy Valve GA Health Company Limited
K200388 02/18/2020 Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector GA Health Company Limited
K200479 02/27/2020 AquaPulse Auxiliary Water Connector GA Health Company Limited
K200481 02/27/2020 Andorate Biopsy Valve, Andorate Biopsy Irrigator GA Health Company Limited
K200495 02/28/2020 Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve GA Health Company Limited
K230932 04/03/2023 ANDORATE« Valve Kit GA Health Company Limited
K191231 05/08/2019 Andorate Auxiliary Water Connector, Andorate Valves Set Smartdata Suzhou Co., Ltd
K191366 05/22/2019 Vacutore Air/Water Bottle Tubing Smartdata Suzhou Co., Ltd
K231602 06/01/2023 Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing GA Health Company Limited
K181509 06/08/2018 Endorate Valve Sets Smartdata Suzhou Co., Ltd
K202560 09/04/2020 AquaPulse Irrigation Tubing GA Health Company Limited
K213095 09/24/2021 andorate Suction Valve, andorate Air/Water Valve GA Health Company Limited
K202838 09/25/2020 Andorate Universal Endoscope Tip Guard GA Health Company Limited
K223171 10/11/2022 AquaPulse« Irrigation Tubing GA Health Company Limited
K182998 10/30/2018 Andorate Auxiliary Water Connector Smartdata Suzhou Co., Ltd


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact