Disposable Endoscopic Distal Attachments— 510(k) K260423
Substantially EquivalentYangzhou Fartley Medical Instrument Technology Co., Ltd.
FDA 510(k) clearance K260423 for Disposable Endoscopic Distal Attachments, Substantially Equivalent on 2026-05-28. Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Device class: 2.
Summary
Yangzhou Fartley Medical Instrument Technology filed the Disposable Endoscopic Distal Attachments under FDF, flexible or rigid colonoscopes and accessories. The device name is generic.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
The company filed from Yangzhou, China. Review took 108 calendar days (February 9 to May 28, 2026).
Clearance details
- Applicant
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Product code
- Product code FDF
- 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 FDF
view allMore clearances from Yangzhou Fartley Medical Instrument Technology Co., Ltd.
view allAdverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
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.