Disposable Valve Sets
FDA 510(k) K192258 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
510(k) numberK192258
Submission
- Device name
- Disposable Valve Sets
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hanzhou, CN - Received
- August 20, 2019
- Decision date
- December 30, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
Other 510(k)s with product code ODC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252933 | Dyne PortODC · Traditional | Dyne Medical Group, Inc. | 06/12/2026SE |
| K250145 | Biopsy Port AdapterODC · Traditional | Endosound, Inc. | 10/17/2025SE |
| K252910 | Orca Air/Water and Suction ValvesODC · Special | Boston Scientific | 10/09/2025SESK |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)ODC · Traditional | Olympus Medical Systems Corporation | 07/16/2025SE |
| K250732 | Disposable Endoscopy Valve SetODC · Traditional | Yangzhou Fartley Medical Instrument Technology… | 06/20/2025SE |
| K241842 | Luer-Split MAJ-2092ODC · Traditional | Olympus Medical Systems Corporation | 03/19/2025SE |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning AdapterODC · Special | Steris Corparation | 02/20/2025SE |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…ODC · Special | STERIS Corporation | 11/08/2024SE |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC · Special | STERIS Corporation | 10/11/2024SE |
| K241285 | Disposable Endoscope Valves Set (AF series)ODC · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 10/01/2024SE |
More from Alton (Shanghai) Medical Instruments Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260410 | Single Use Ureteral Access SheathFED · Special | 09/11/2026SE |
| K253132 | Single use stone retrieval balloonsFGE · Traditional | 03/06/2026SE |
| K251890 | Disposable Ureteral StentsFAD · Traditional | 02/20/2026SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | 09/08/2023SE |
| 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 |
Questions and answers
When was Disposable Valve Sets cleared by the FDA?
Disposable Valve Sets (K192258) received a 510(k) decision of Substantially Equivalent on December 30, 2019, 132 days after the submission was received.
What is the product code of K192258?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.