K254153
- 510(k) number
- K254153
- Device name
- Single-use Video Scope; PB Digital Controller
- Applicant
- Mirco-Tech (Nanjing) Co., Ltd. CN
- Product code
- FBN — Choledochoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-04-03
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254153.pdf
Official FDA record: K254153
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.