Single-use Ureteral Access Sheath
FDA 510(k) K240167 · Hunan Vathin Medical Instrument Co., Ltd.
510(k) numberK240167
Submission
- Device name
- Single-use Ureteral Access Sheath
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd.
Xingtan, CN - Received
- January 22, 2024
- Decision date
- October 8, 2024
- 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 |
|---|---|---|
| K250232 | Vathin® Video Bronchoscope SystemEOQ · Traditional | 07/25/2025SE |
| K251599 | Single-use Ureteral Access SheathFED · Special | 07/03/2025SE |
| K250785 | Single-use Flexible UreteroscopeFGB · Traditional | 05/06/2025SE |
| K243117 | Digital Video ProcessorFGB · Traditional | 01/29/2025SE |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…EOQ · Traditional | 01/16/2025SE |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…FAJ · Traditional | 12/18/2024SE |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L…EOQ · Traditional | 10/29/2024SE |
| K241434 | Video Ureteroscope SystemFGB · Special | 10/04/2024SE |
| K231135 | Video Ureteroscope SystemFGB · Traditional | 01/17/2024SE |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video MonitorEOB · Traditional | 06/14/2023SE |
Questions and answers
When was Single-use Ureteral Access Sheath cleared by the FDA?
Single-use Ureteral Access Sheath (K240167) received a 510(k) decision of Substantially Equivalent on October 8, 2024, 260 days after the submission was received.
What is the product code of K240167?
The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.