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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 / K254153

510(k) cleared

Single-use Video Scope; PB Digital Controller

Mirco-Tech (Nanjing) Co., Ltd. · Apr 3, 2026 · K254153

FDA cleared the Single-use Video Scope; PB Digital Controller from Mirco-Tech (Nanjing) Co., Ltd. on Apr 3, 2026 under K254153, a traditional 510(k). The device falls under product code FBN, Choledochoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 22, 2025. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mirco-Tech (Nanjing) Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K260262 (Injection Needle), K253832 (Dilation Balloon Catheter), K253139 (Disposable Distal Cap).

Questions & Answers

What did FDA clear under K254153?

K254153 is the FDA 510(k) for Single-use Video Scope; PB Digital Controller, submitted by Mirco-Tech (Nanjing) Co., Ltd.. FDA's decision date was Apr 3, 2026, under product code FBN (Choledochoscope And Accessories, Flexible/Rigid).

Who makes the Single-use Video Scope; PB Digital Controller?

Mirco-Tech (Nanjing) Co., Ltd., based in Nanjing, is the applicant of record for K254153.

How long did the K254153 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Apr 3, 2026, 102 days later.

← All decisions in April 2026

Sources