Data / Medical devices / Hong Kong / Ga Health Company Limited
Ga Health Company Limited: FDA-registered device maker in Hong Kong, Hong Kong, 14 510(k) clearances
Ga Health Company Limited is registered with the FDA (registration 3014749926) in Hong Kong, Hong Kong. It lists 11 device types. The FDA files 14 510(k) clearances under its listings, the newest dated October 16, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014749926
- Address
- Unit 1511-13 & 15, 15/F, Tower 2, Grand Central Plaza 138 Shatin Rural Committee Road, Shatin, N.T., Hong Kong, Hong Kong, None
- Owner or operator
- GA Health Company Limited (10061258)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 8, 2019
- Registered through
- 2026
- Brand names listed
- 101037A, 101047, 101067, 101093, 101048, 101068, 101094, 101087A, Andorate, ENDO004US, ENDO015SUS, ENDO018SUS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Bottle, Collection And Trap, Breathing System (Uncalibrated) | CBC | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Bronchoscope Accessory | KTI | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Endoscopic Storage Cover | OCU | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Complaint file establishment, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 16, 2023 | K232118 | ANDORATE® Valve Kit | ODC | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| August 1, 2023 | K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | OCX | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| July 7, 2023 | K230932 | ANDORATE® Valve Kit | OCX | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| May 11, 2023 | K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | KTI | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| November 10, 2022 | K223171 | AquaPulse® Irrigation Tubing | OCX | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| March 5, 2021 | K202838 | Andorate Universal Endoscope Tip Guard | OCU | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| June 24, 2020 | K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve | ODC | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| June 18, 2020 | K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | ODC | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| May 15, 2020 | K200479 | AquaPulse Auxiliary Water Connector | OCX | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| April 14, 2020 | K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector | OCX | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| September 6, 2019 | K191366 | Vacutore Air/Water Bottle Tubing | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| June 7, 2019 | K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | ODC | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| April 17, 2019 | K182998 | Andorate Auxiliary Water Connector | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| July 6, 2018 | K181509 | Endorate Valve Sets | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 3, 2020 | 86763 | Class II | Terminated | STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscope Channel Accessory
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Adaptor, Bulbs, Miscellaneous, For Endoscope
- All makers of Endoscopic Irrigation/Suction System
- All makers of Bottle, Collection And Trap, Breathing System (Uncalibrated)
- All makers of Endoscopic Storage Cover
Updated October 16, 2023. 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.