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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K252492

510(k) cleared

Visualized Access and Delivery Catheter; PB Digital Controller

Micro-Tech (Nanjing) Co., Ltd. · Apr 24, 2026 · K252492

FDA cleared the Visualized Access and Delivery Catheter; PB Digital Controller from Micro-Tech (Nanjing) Co., Ltd. on Apr 24, 2026 under K252492, a traditional 510(k). The device falls under product code SHU, Appendiceal Scope And Accessories, Flexible, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 8, 2025. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Micro-Tech (Nanjing) Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K251692 (Advanced Tissue Resection Device), K250229 (Dual Action Tissue Closure Device).

Questions & Answers

What did FDA clear under K252492?

K252492 is the FDA 510(k) for Visualized Access and Delivery Catheter; PB Digital Controller, submitted by Micro-Tech (Nanjing) Co., Ltd.. FDA's decision date was Apr 24, 2026, under product code SHU (Appendiceal Scope And Accessories, Flexible).

Who makes the Visualized Access and Delivery Catheter; PB Digital Controller?

Micro-Tech (Nanjing) Co., Ltd., based in Nanjing, is the applicant of record for K252492.

How long did the K252492 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Apr 24, 2026, 259 days later.

← All decisions in April 2026

Sources