Air/Water Bottle Tubing, CO2 Source Tubing
FDA 510(k) K231471 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
510(k) numberK231471
Submission
- Device name
- Air/Water Bottle Tubing, CO2 Source Tubing
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hangzhou, CN - Received
- May 22, 2023
- Decision date
- September 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K231418 | ENDOGATOR Hybrid Irrigation TubingOCX · Traditional | Medivators | 08/14/2023SE |
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| K251890 | Disposable Ureteral StentsFAD · Traditional | 02/20/2026SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | 11/21/2023SE |
| K220063 | Single Use Cytology BrushFDX · Traditional | 07/28/2022SE |
| K212669 | Single Use HemoclipPKL · Traditional | 05/27/2022SE |
| K220065 | Single Use Ureteral Access SheathFED · Traditional | 05/25/2022SE |
| K212668 | Sclerotherapy NeedleFBK · Traditional | 02/23/2022SE |
| K191900 | Single Use Grasping ForcepsOCZ · Traditional | 03/27/2020SE |
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Questions and answers
When was Air/Water Bottle Tubing, CO2 Source Tubing cleared by the FDA?
Air/Water Bottle Tubing, CO2 Source Tubing (K231471) received a 510(k) decision of Substantially Equivalent on September 8, 2023, 109 days after the submission was received.
What is the product code of K231471?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.