Clean Connecting Tube
FDA 510(k) K220785 · Yangzhou Fartley Medical Instrument Technology Co., Ltd.
510(k) numberK220785
Submission
- Device name
- Clean Connecting Tube
- Applicant
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Yangzhou, CN - Received
- March 17, 2022
- Decision date
- September 27, 2022
- 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 |
| 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 |
|---|---|---|
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | 05/28/2026SE |
| K250732 | Disposable Endoscopy Valve SetODC · Traditional | 06/20/2025SE |
| K230004 | Disposable HemoclipPKL · Traditional | 07/31/2023SE |
| K222980 | Pentax Medical Valve SetODC · Traditional | 11/21/2022SE |
| K220292 | Disposable Endoscope Injection NeedleFBK · Traditional | 08/19/2022SE |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareFDI · Traditional | 06/27/2022SE |
| K220210 | Disposable Endoscopy Adapter SetODC · Traditional | 06/17/2022SE |
Questions and answers
When was Clean Connecting Tube cleared by the FDA?
Clean Connecting Tube (K220785) received a 510(k) decision of Substantially Equivalent on September 27, 2022, 194 days after the submission was received.
What is the product code of K220785?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.