GA Health Company Limited
Hong Kong, HK
GA HEALTH COMPANY LIMITED appears in FDA device records in Hong Kong, HK. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 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 12 510(k) clearances for GA Health Company Limited between 2020 and 2023. The busiest year on record is 2020, with 5. The most recent is 2023, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232118 | ANDORATE® Valve Kit | ODC | Substantially Equivalent | |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | OCX | Substantially Equivalent | |
| K230932 | ANDORATE® Valve Kit | OCX | Substantially Equivalent | |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | KTI | Substantially Equivalent | |
| K223171 | AquaPulse® Irrigation Tubing | OCX | Substantially Equivalent | |
| K213095 | andorate Suction Valve, andorate Air/Water Valve | ODC | Substantially Equivalent | |
| K202838 | Andorate Universal Endoscope Tip Guard | OCU | Substantially Equivalent | |
| K202560 | AquaPulse Irrigation Tubing | OCX | Substantially Equivalent | |
| K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve | ODC | Substantially Equivalent | |
| K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | ODC | Substantially Equivalent | |
| K200479 | AquaPulse Auxiliary Water Connector | OCX | Substantially Equivalent | |
| K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector | OCX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014749926 | 3014749926 | GA HEALTH COMPANY LIMITED | Unit 1511-13 & 15, 15/F, Tower 2, Grand Central Plaza, Hong Kong None HK | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)
- KTIBronchoscope Accessory
- ODCEndoscope Channel Accessory
- MNKEndoscopic Bite Block
- OCXEndoscopic Irrigation/Suction System
- OCUEndoscopic Storage Cover
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- HMPPad, Eye
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0649-2021 | ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0648-2021 | ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0647-2021 | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0646-2021 | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0645-2021 | Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0644-2021 | Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0643-2021 | Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0642-2021 | STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0641-2021 | STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0640-2021 | STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1 | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure | Class II | Terminated | |
| Z-0639-2021 | 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 | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain