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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 / March 2026 / K253139

510(k) cleared

Disposable Distal Cap

Mirco-Tech (Nanjing) Co., Ltd. · Mar 19, 2026 · K253139

FDA cleared the Disposable Distal Cap from Mirco-Tech (Nanjing) Co., Ltd. on Mar 19, 2026 under K253139, 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 Sep 25, 2025. The decision came 175 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), K254153 (Single-use Video Scope; PB Digital Controller).

Questions & Answers

What did FDA clear under K253139?

K253139 is the FDA 510(k) for Disposable Distal Cap, submitted by Mirco-Tech (Nanjing) Co., Ltd.. FDA's decision date was Mar 19, 2026, under product code FBN (Choledochoscope And Accessories, Flexible/Rigid).

Who makes the Disposable Distal Cap?

Mirco-Tech (Nanjing) Co., Ltd., based in Nanjing, is the applicant of record for K253139.

How long did the K253139 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Mar 19, 2026, 175 days later.

← All decisions in March 2026

Sources