Micro-Tech (Nanjing) Co., Ltd. - FDA 510(k) Cleared Devices

Micro-Tech (Nanjing) Co., Ltd. is a medical device manufacturer based in Nanjing, China. Founded in 2000, the company specializes in minimally invasive medical devices for clinical diagnosis and treatment.

The company has received 41 FDA 510(k) clearances from 41 total submissions, with no denied submissions on record. 83% of submissions focus on Gastroenterology & Urology devices, including tissue resection systems, closure devices, stents, and endoscopic accessories. The company's regulatory activity spans from 2015 to 2026, with recent clearances demonstrating continued innovation in endoscopic and bronchial ultrasound technologies.

Micro-Tech operates a global presence across North America, Europe, and Asia-Pacific. The company is known for flagship products including tissue closure systems and single-use endoscopic platforms. Its regulatory record reflects consistent focus on minimally invasive procedural devices for gastroenterology, urology, and anesthesiology applications.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the database.

510(k) submissions have been managed by Mirco-Tech (Nanjing) Co., Ltd. as regulatory consultant.