Visualized Access and Delivery Catheter; PB Digital Controller— 510(k) K252492

Name: FDA 510(k) clearance K252492
Creator: U.S. Food and Drug Administration
Published: 2026-04-24

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K252492 for Visualized Access and Delivery Catheter; PB Digital Controller, Substantially Equivalent on 2026-04-24. Applicant: Micro-Tech (Nanjing) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code SHU
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-08
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

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