Single Use Ureteral Access Sheath
FDA 510(k) K220065 · Zhejiang Chuangxiang Medical Technology Co., Ltd.
510(k) numberK220065
Submission
- Device name
- Single Use Ureteral Access Sheath
- Applicant
- Zhejiang Chuangxiang Medical Technology Co., Ltd.
Hangzhou, CN - Received
- January 10, 2022
- Decision date
- May 25, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FED – Endoscopic Access Overtube, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Other 510(k)s with product code FED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260410 | Single Use Ureteral Access SheathFED · Special | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/11/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | Boston Scientific Corporation | 08/04/2026SE |
| K260965 | CVAC Aspiration SystemFED · Special | Calyxo, Inc. | 04/13/2026SE |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050…FED · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 04/06/2026SE |
| K252572 | Prodeon Urethral Sheath SystemFED · Traditional | Prodeon Medical, Inc. | 10/07/2025SE |
| K250128 | Single Use Suction-Evacuation Ureteral Access SheathFED · Traditional | Anhui Happiness Workshop Medical Instruments… | 09/19/2025SE |
| K250132 | Ureteral Access SheathFED · Traditional | Zhejiang YiGao Medical Technology Co., Ltd. | 09/05/2025SE |
| K250695 | Single-use Ureteral Access SheathFED · Traditional | Shenzhen HugeMed Medical Technical Development… | 07/08/2025SE |
| K251599 | Single-use Ureteral Access SheathFED · Special | Hunan Vathin Medical Instrument Co., Ltd. | 07/03/2025SE |
| K250585 | LumenaTM Ureteral Access SheathFED · Traditional | Cathegenix (Xiamen) Co., Ltd. | 06/27/2025SE |
More from Cathegenix (Xiamen) 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 |
| K212668 | Sclerotherapy NeedleFBK · Traditional | 02/23/2022SE |
| K191900 | Single Use Grasping ForcepsOCZ · Traditional | 03/27/2020SE |
| K192258 | Disposable Valve SetsODC · Traditional | 12/30/2019SE |
Questions and answers
When was Single Use Ureteral Access Sheath cleared by the FDA?
Single Use Ureteral Access Sheath (K220065) received a 510(k) decision of Substantially Equivalent on May 25, 2022, 135 days after the submission was received.
What is the product code of K220065?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.