Chrysalis Intelligence · Sponsors · Ga Health Company Limited

Ga Health Company Limited

Hong Kong, CN · 12 510(k) clearances · 11 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
12
2020-04-14 → 2023-10-16
Last 12 months
0
Product codes
4
Most recent
2023-10-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OCX — — — 6 2023-08-01
ODC Endoscope Channel Accessory Class II Gastroenterology, Urology 4 2023-10-16
KTI Bronchoscope Accessory Class II Ear, Nose, Throat 1 2023-05-11
OCU Endoscopic Storage Cover Class II Gastroenterology, Urology 1 2021-03-05
Safety

Recalls (11)

Class I (serious)
0
Risk of injury / death
Total recalls
11
Currently ongoing
0
Most recent
2020-11-03
DateSeverityStatusRecall # ProductCodeReason
2020-11-03 Class II Terminated Z-0649-2021 ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Produ… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 Class II Terminated Z-0648-2021 ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 1… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 Class II Terminated Z-0647-2021 Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diver… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 Class II Terminated Z-0646-2021 Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Hea… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 Class II Terminated Z-0645-2021 Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: … — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 Class II Terminated Z-0644-2021 Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Pro… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 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
2020-11-03 Class II Terminated Z-0642-2021 STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 Class II Terminated Z-0641-2021 STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGIC… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 Class II Terminated Z-0640-2021 STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRI… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
2020-11-03 Class II Terminated Z-0639-2021 STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUT… — Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2023-10-16 K232118 ANDORATE® Valve Kit ODC Class II Gastroenterology, Urology
2023-08-01 K231602 Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing OCX — —
2023-07-07 K230932 ANDORATE® Valve Kit OCX — —
2023-05-11 K230280 ANDORATE® Suction Valve and ANDORATE® Biopsy Valve KTI Class II Ear, Nose, Throat
2022-11-10 K223171 AquaPulse® Irrigation Tubing OCX — —
2022-01-12 K213095 andorate Suction Valve, andorate Air/Water Valve ODC Class II Gastroenterology, Urology
2021-03-05 K202838 Andorate Universal Endoscope Tip Guard OCU Class II Gastroenterology, Urology
2020-12-10 K202560 AquaPulse Irrigation Tubing OCX — —
2020-06-24 K200495 Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve ODC Class II Gastroenterology, Urology
2020-06-18 K200481 Andorate Biopsy Valve, Andorate Biopsy Irrigator ODC Class II Gastroenterology, Urology
2020-05-15 K200479 AquaPulse Auxiliary Water Connector OCX — —
2020-04-14 K200388 Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector OCX — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence