Medical Device Manufacturer · CN , Shenzhen

MacroLux Medical Technology Co., Ltd.

5 submissions · 5 cleared · Since 2024

5

Total

5

Cleared

0

Denied

MacroLux Medical Technology Co., Ltd. — FDA 510(k) Submissions

MacroLux Medical Technology Co., Ltd. has submitted 5 FDA 510(k) premarket notifications since 2024, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hysteroscope (and Accessories), Endoscopic Access Overtube, Gastroenterology-urology, Ureteroscope And Accessories, Flexible/rigid, Bronchoscope (flexible Or Rigid), Cystoscope And Accessories, Flexible/rigid . Use the specialty filter in the sidebar to narrow results.

5 devices

1–5 of 5

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)

K250452 · FED Endoscopic Access... · Gastroenterology & Urology

SeleneView? Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

K240978 · HIH Hysteroscope (and... · Obstetrics & Gynecology

BubbleView? Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub? Video Processor (S13, S13-T, S13-N, S13-S)

K240283 · FAJ Cystoscope And... · Gastroenterology & Urology

LoopView? Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub? Video Processor (S13)

K233779 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat

CoralView? Single-use Digital Flexible Ureteroscope (U10); CoralView? Single-use Digital Flexible Ureteroscope (U10-B); CoralView? Single-use Digital Flexible Ureteroscope (U10-BR); CoralView? Single-use Digital Flexible Ureteroscope (U20); CoralView? Single-use Digital Flexible Ureteroscope (U20-B); CoralView? Single-use Digital Flexible Ureteroscope (U20-BR)

K231774 · FGB Ureteroscope And... · Gastroenterology & Urology