Medical Device Manufacturer · CN , Nanjing

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

5 submissions · 5 cleared · Since 2024

Recent clearances: Injection Needle, Dilation Balloon Catheter, Single-use Video Scope

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mirco-Tech (Nanjing) Co., Ltd. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared May 29, 2026

Injection Needle

Gastroenterology & Urology · 121d

Cleared Apr 24, 2026

Dilation Balloon Catheter

Gastroenterology & Urology · 144d

Cleared Apr 03, 2026

Single-use Video Scope

Gastroenterology & Urology · 102d

Cleared Mar 19, 2026

Disposable Distal Cap

Gastroenterology & Urology · 175d

Cleared Mar 19, 2024

Disposable Dual Action Tissue Closure Device

Gastroenterology & Urology · 116d