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.

Summary

Micro-Tech (Nanjing)'s record names two devices: the Visualized Access and Delivery Catheter and the PB Digital Controller. Both are filed under product code SHU (Appendiceal Scope And Accessories, Flexible), and the record doesn't describe either one beyond its name.

Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Micro-Tech (Nanjing) filed from Nanjing, China. The decision came 259 calendar days after FDA received it (August 8, 2025 to April 24, 2026).

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Product 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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