Medical Device Manufacturer · CN , Shenzhen

MacroLux Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2024

5

Total

5

Cleared

0

Denied

FDA 510(k) cleared devices by MacroLux Medical Technology Co., Ltd. Gastroenterology & Urology ✕

3 devices

1-3 of 3

Cleared Jun 02, 2025

CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B,...

Gastroenterology & Urology · 104d

Cleared Jun 10, 2024

BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB,...

Gastroenterology & Urology · 130d

Cleared Jan 11, 2024

CoralView® Single-use Digital Flexible Ureteroscope (U10)

Gastroenterology & Urology · 209d