Company · CN
Ga Health Company Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2023. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2023 | K232118 | ANDORATE® Valve Kit Ga Health Company Limited, CN | ODC |
| Aug 1, 2023 | K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing Ga Health Company Limited, HK | OCX |
| Jul 7, 2023 | K230932 | ANDORATE® Valve Kit Ga Health Company Limited, CN | OCX |
| May 11, 2023 | K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve Ga Health Company Limited, HK | KTI |
| Nov 10, 2022 | K223171 | AquaPulse® Irrigation Tubing Ga Health Company Limited, CN | OCX |
| Jan 12, 2022 | K213095 | andorate Suction Valve, andorate Air/Water Valve Ga Health Company Limited, CN | ODC |
| Mar 5, 2021 | K202838 | Andorate Universal Endoscope Tip Guard Ga Health Company Limited, CN | OCU |
| Dec 10, 2020 | K202560 | AquaPulse Irrigation Tubing Ga Health Company Limited, CN | OCX |
| Jun 24, 2020 | K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve Ga Health Company Limited, CN | ODC |
| Jun 18, 2020 | K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator Ga Health Company Limited, CN | ODC |
| May 15, 2020 | K200479 | AquaPulse Auxiliary Water Connector Ga Health Company Limited, CN | OCX |
| Apr 14, 2020 | K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector Ga Health Company Limited, CN | OCX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED ScopeValet Guardian Disposable Endoscope Valves Set-
Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector
Product Code: 345SVVO4 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501
Product Code: 345SVVO1 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus
Product Code: GAR3846 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector
Product Code: GAR046 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve
Product Code: GAR004 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED STOPCON Suction Valve-Suction Valve for GI-Endoscope
DISTRIBUTED BY: KEY SURGICAL
8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA
Product Code: EN10232 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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 Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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 C Terminated |
OCX | K181509 K182998 |
| Nov 3, 2020 | GA HEALTH COMPANY LIMITED 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 Terminated |
OCX | K181509 K182998 |