Ga Health Company Limited
Ga Health Company Limited holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2023, with 11 FDA device recalls on record.
Top product codes for Ga Health Company Limited
FDA recalls by Ga Health Company Limited
10 most recent of 11- Z-0648-2021 — ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
- 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
- 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
- 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
- Z-0645-2021 — Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
- Z-0643-2021 — Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
- 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
- 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
- Z-0649-2021 — ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
- 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ga Health Company Limited
- K232118 — ANDORATE® Valve Kit
- K231602 — Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
- K230932 — ANDORATE® Valve Kit
- K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
- K223171 — AquaPulse® Irrigation Tubing
- K213095 — andorate Suction Valve, andorate Air/Water Valve
- K202838 — Andorate Universal Endoscope Tip Guard
- K202560 — AquaPulse Irrigation Tubing
- K200495 — Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
- K200481 — Andorate Biopsy Valve, Andorate Biopsy Irrigator
- K200479 — AquaPulse Auxiliary Water Connector
- K200388 — Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
Data sourced from openFDA. This site is unofficial and independent of the FDA.