Disposable Ureteral Access Sheath— 510(k) K260512
Substantially EquivalentYangzhou Fartley Medical Instrument Technology Co., Ltd.
FDA 510(k) clearance K260512 for Disposable Ureteral Access Sheath, Substantially Equivalent on 2026-09-21. Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Device class: 2.
Summary
This is a disposable ureteral access sheath, filed under FED, gastroenterology-urology endoscopic access overtubes. Ureteral access sheaths give an endoscope a path into the ureter. The record doesn't give sizes or a product name beyond the generic description.
Class II, 21 CFR 876.1500. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).
Yangzhou Fartley Medical Instrument Technology Co., Ltd. filed from Yangzhou, China. Review took 216 days (February 17 to September 21, 2026).
Clearance details
- Applicant
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Product code
- Product code FED
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yangzhou, CN
Recent devices under product code FED
view allMore clearances from Yangzhou Fartley Medical Instrument Technology Co., Ltd.
view allAdverse events under product code FED
product code FED- Death
- 10
- Total
- 10
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.