GA HEALTH COMPANY LIMITED
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0649-2021 | Class II | ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Wa | November 3, 2020 |
| Z-0648-2021 | Class II | ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore A | November 3, 2020 |
| Z-0647-2021 | Class II | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water | November 3, 2020 |
| Z-0639-2021 | Class II | STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy | November 3, 2020 |
| Z-0642-2021 | Class II | STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROA | November 3, 2020 |
| Z-0645-2021 | Class II | Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olymp | November 3, 2020 |
| Z-0643-2021 | Class II | Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve | November 3, 2020 |
| Z-0646-2021 | Class II | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured | November 3, 2020 |
| Z-0640-2021 | Class II | STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water | November 3, 2020 |
| Z-0641-2021 | Class II | STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRI | November 3, 2020 |
| Z-0644-2021 | Class II | Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Wa | November 3, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232118 | ANDORATE® Valve Kit | October 16, 2023 |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | August 1, 2023 |
| K230932 | ANDORATE® Valve Kit | July 7, 2023 |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | May 11, 2023 |
| K223171 | AquaPulse® Irrigation Tubing | November 10, 2022 |
| K213095 | andorate Suction Valve, andorate Air/Water Valve | January 12, 2022 |
| K202838 | Andorate Universal Endoscope Tip Guard | March 5, 2021 |
| K202560 | AquaPulse Irrigation Tubing | December 10, 2020 |
| K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve | June 24, 2020 |
| K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | June 18, 2020 |
| K200479 | AquaPulse Auxiliary Water Connector | May 15, 2020 |
| K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector | April 14, 2020 |