K253139
- 510(k) number
- K253139
- Device name
- Disposable Distal Cap
- Applicant
- Mirco-Tech (Nanjing) Co., Ltd. CN
- Product code
- FBN — Choledochoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-03-19
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253139.pdf
Official FDA record: K253139
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.