Cleared Traditional

K252492 - Visualized Access and Delivery Catheter (FDA 510(k) Clearance)

Also includes:
PB Digital Controller
K252492 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
259d
Days
-
Risk

K252492 is an FDA 510(k) clearance for the Visualized Access and Delivery Catheter.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on April 24, 2026 after a review of 259 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K252492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2025
Decision Date April 24, 2026
Days to Decision 259 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 130d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SHU
Device Class -

Regulatory Consultant

Mirco-Tech (Nanjing) Co., Ltd.
Sally He

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.