MacroLux Medical Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG), CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B), SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - MacroLux Medical Technology Co., Ltd. Gastroenterology & Urology ✕
3 devices
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