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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 / February 2026 / K251692

510(k) cleared

Advanced Tissue Resection Device

Micro-Tech (Nanjing) Co., Ltd. · Feb 21, 2026 · K251692

FDA cleared the Advanced Tissue Resection Device from Micro-Tech (Nanjing) Co., Ltd. on Feb 21, 2026 under K251692, a traditional 510(k). The device falls under product code FDI, Snare, Flexible, regulated at 21 CFR 876.4300 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 2, 2025. The decision came 264 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: K252492 (Visualized Access and Delivery Catheter; PB Digital Controller), K250229 (Dual Action Tissue Closure Device).

Questions & Answers

What did FDA clear under K251692?

K251692 is the FDA 510(k) for Advanced Tissue Resection Device, submitted by Micro-Tech (Nanjing) Co., Ltd.. FDA's decision date was Feb 21, 2026, under product code FDI (Snare, Flexible).

Who makes the Advanced Tissue Resection Device?

Micro-Tech (Nanjing) Co., Ltd., based in Nanjing, is the applicant of record for K251692.

How long did the K251692 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Feb 21, 2026, 264 days later.

← All decisions in February 2026

Sources