K252492
- 510(k) number
- K252492
- Device name
- Visualized Access and Delivery Catheter; PB Digital Controller
- Applicant
- Micro-Tech (Nanjing) Co., Ltd. CN
- Product code
- SHU — Appendiceal Scope And Accessories, Flexible
- Decision date
- 2026-04-24
- Date received
- 2025-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K252492.pdf
Official FDA record: K252492
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.