AquaPulse Auxiliary Water Connector
FDA 510(k) K200479 · Ga Health Company Limited
510(k) numberK200479
Submission
- Device name
- AquaPulse Auxiliary Water Connector
- Applicant
- Ga Health Company Limited
Hong Kong, CN - Received
- February 27, 2020
- Decision date
- May 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- OCX – Endoscopic Irrigation/Suction System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Other 510(k)s with product code OCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251986 | Auxiliary Water Tube MAJ-855OCX · Traditional | Olympus Medical Systems Corporation | 09/26/2025SE |
| K251997 | Single-Use Biopsy Valve (MAJ-1555)OCX · Traditional | Olympus Medical Systems Corporation | 09/25/2025SE |
| K242586 | ArgoCap (200.52)OCX · Traditional | Ovesco Endoscopy AG | 05/22/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | Hangzhou AGS MedTech Co., Ltd. | 03/20/2025SE |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902)OCX · Traditional | Olympus Medical Systems Corporation | 10/07/2024SE |
| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
| K242134 | ClearCap Distal AttachmentOCX · Special | Finemedix Co., Ltd. | 08/20/2024SE |
| K233442 | troCarWash SystemOCX · Traditional | Biotex, Inc. | 05/21/2024SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/08/2023SE |
More from Zhejiang Chuangxiang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232118 | ANDORATE® Valve KitODC · Traditional | 10/16/2023SE |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid TubingOCX · Traditional | 08/01/2023SE |
| K230932 | ANDORATE® Valve KitOCX · Traditional | 07/07/2023SE |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy ValveKTI · Traditional | 05/11/2023SE |
| K223171 | AquaPulse® Irrigation TubingOCX · Special | 11/10/2022SE |
| K213095 | andorate Suction Valve, andorate Air/Water ValveODC · Traditional | 01/12/2022SE |
| K202838 | Andorate Universal Endoscope Tip GuardOCU · Traditional | 03/05/2021SE |
| K202560 | AquaPulse Irrigation TubingOCX · Traditional | 12/10/2020SE |
| K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveODC · Traditional | 06/24/2020SE |
| K200481 | Andorate Biopsy Valve, Andorate Biopsy IrrigatorODC · Traditional | 06/18/2020SE |
Questions and answers
When was AquaPulse Auxiliary Water Connector cleared by the FDA?
AquaPulse Auxiliary Water Connector (K200479) received a 510(k) decision of Substantially Equivalent on May 15, 2020, 78 days after the submission was received.
What is the product code of K200479?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.