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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 / September 2025 / K250229

510(k) cleared

Dual Action Tissue Closure Device

Micro-Tech (Nanjing) Co., Ltd. · Sep 8, 2025 · K250229

FDA cleared the Dual Action Tissue Closure Device from Micro-Tech (Nanjing) Co., Ltd. on Sep 8, 2025 under K250229, a traditional 510(k). The device falls under product code PKL, Hemostatic Metal Clip For The Gi Tract, regulated at 21 CFR 876.4400 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 27, 2025. The decision came 224 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), K251692 (Advanced Tissue Resection Device).

Questions & Answers

What did FDA clear under K250229?

K250229 is the FDA 510(k) for Dual Action Tissue Closure Device, submitted by Micro-Tech (Nanjing) Co., Ltd.. FDA's decision date was Sep 8, 2025, under product code PKL (Hemostatic Metal Clip For The Gi Tract).

Who makes the Dual Action Tissue Closure Device?

Micro-Tech (Nanjing) Co., Ltd., based in Nanjing, is the applicant of record for K250229.

How long did the K250229 review take?

FDA received the submission on Jan 27, 2025 and issued its decision on Sep 8, 2025, 224 days later.

← All decisions in September 2025

Sources