Single-use Ureteral Access Sheath
FDA 510(k) K250695 · Shenzhen HugeMed Medical Technical Development Co., Ltd.
510(k) numberK250695
Submission
- Device name
- Single-use Ureteral Access Sheath
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
Shenzhen, CN - Received
- March 7, 2025
- Decision date
- July 8, 2025
- 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 |
| 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 |
| K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B…FED · Traditional | MacroLux Medical Technology Co., Ltd. | 06/02/2025SE |
More from MacroLux Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260892 | Suction Pump (SU-90)BTA · Traditional | 05/14/2026SE |
| K241444 | Biliary Pancreaticobiliary Scope SystemFBN · Traditional | 01/21/2025SE |
| K240374 | Ureterorenoscope SystemFGB · Traditional | 05/10/2024SE |
| K232435 | Rhinolaryngoscope systemEOB · Traditional | 04/26/2024SE |
| K231497 | Choledochoscope SystemFBN · Traditional | 03/06/2024SE |
| K231118 | Cystoscope SystemFAJ · Traditional | 11/13/2023SE |
| K222910 | Bronchoscope SystemEOQ · Traditional | 04/11/2023SE |
Questions and answers
When was Single-use Ureteral Access Sheath cleared by the FDA?
Single-use Ureteral Access Sheath (K250695) received a 510(k) decision of Substantially Equivalent on July 8, 2025, 123 days after the submission was received.
What is the product code of K250695?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.