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510(k) K231602

Device
Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
Applicant
Ga Health Company Limited
510(k) number
K231602
Product code
OCX
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-01
Date received
2023-06-01
Regulation
876.1500
Classification name
Endoscopic Irrigation/Suction System
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cindy Ye
Address
Unit 18, 21/F, Metropole Sq., 2 On Yiu St., Shatin Hong Kong HK

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems Corporation2025-09-26
K251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation2025-09-25
K242586ArgoCap (200.52)Ovesco Endoscopy AG2025-05-22
K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.2025-03-20
K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems Corporation2024-10-07
K241874Aspiration Catheter (2189)Hobbs Medical, Inc.2024-09-24
K242134ClearCap Distal AttachmentFinemedix Co., Ltd.2024-08-20
K233442troCarWash™ SystemBiotex, Inc.2024-05-21
K230773Endoscopy Irrigation TubingZhejiang Chuangxiang Medical Technology Co., Ltd.2023-11-21
K231471Air/Water Bottle Tubing, CO2 Source TubingZhejiang Chuangxiang Medical Technology Co., Ltd.2023-09-08
K231418ENDOGATOR™ Hybrid Irrigation TubingMedivators2023-08-14
K230932ANDORATE® Valve KitGa Health Company Limited2023-07-07
K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc.2023-02-27
K222695troCarWash™ SystemBiotex, Inc.2023-02-17
K223171AquaPulse® Irrigation TubingGa Health Company Limited2022-11-10