FDA 510(k) Applications Submitted by MacroLux Medical Technology Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240283 |
02/01/2024 |
BubbleViewÖ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub« Video Processor (S13, S13-T, S13-N, S13-S) |
MacroLux Medical Technology Co., Ltd. |
| K240978 |
04/10/2024 |
SeleneView« Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) |
MacroLux Medical Technology Co., Ltd. |
| K231774 |
06/16/2023 |
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« Sin |
MacroLux Medical Technology Co., Ltd. |
| K233779 |
11/27/2023 |
LoopView« Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub« Video Processor (S13) |
MacroLux Medical Technology Co., Ltd. |
| K250452 |
02/18/2025 |
CoralWellÖ 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, |
MacroLux Medical Technology Co., Ltd. |
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