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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 / May 2026 / K260262

510(k) cleared

Injection Needle

Mirco-Tech (Nanjing) Co., Ltd. · May 29, 2026 · K260262

FDA cleared the Injection Needle from Mirco-Tech (Nanjing) Co., Ltd. on May 29, 2026 under K260262, a traditional 510(k). The device falls under product code FBK, Endoscopic Injection Needle, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 28, 2026. The decision came 121 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: K253832 (Dilation Balloon Catheter), K254153 (Single-use Video Scope; PB Digital Controller), K253139 (Disposable Distal Cap).

Questions & Answers

What did FDA clear under K260262?

K260262 is the FDA 510(k) for Injection Needle, submitted by Mirco-Tech (Nanjing) Co., Ltd.. FDA's decision date was May 29, 2026, under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology).

Who makes the Injection Needle?

Mirco-Tech (Nanjing) Co., Ltd., based in Nanjing, is the applicant of record for K260262.

How long did the K260262 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on May 29, 2026, 121 days later.

← All decisions in May 2026

Sources