K260423
- 510(k) number
- K260423
- Device name
- Disposable Endoscopic Distal Attachments
- Applicant
- Yangzhou Fartley Medical Instrument Technology Co., Ltd. CN
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-05-28
- Date received
- 2026-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K260423.pdf
Official FDA record: K260423
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.