MacroLux Medical Technology Co., Ltd.
FDA 510(k) & PMA Approved Devices — 6 products
Total Devices6
Categories5
Latest Approval2026-04-08
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | EOQ | 2026-04-08 | View |
| 510(k) | K250452 | 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) | FED | 2025-06-02 | View |
| 510(k) | K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | HIH | 2024-08-16 | View |
| 510(k) | K240283 | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) | FAJ | 2024-06-10 | View |
| 510(k) | K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | EOQ | 2024-04-05 | View |
| 510(k) | K231774 | 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) | FGB | 2024-01-11 | View |
No matching devices.