Chrysalis Intelligence · Sponsors · MacroLux Medical Technology Co., Ltd.

MacroLux Medical Technology Co., Ltd.

Shenzhen, CN · 7 510(k) clearances

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Total clearances

7

2024-01-11 → 2026-07-20

Last 12 months

2

Product codes

5

Most recent

2026-07-20

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
FGB	—	—	—	2	2026-07-20
EOQ	Bronchoscope (Flexible Or Rigid)	Class II	Ear, Nose, Throat	2	2026-04-08
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Class II	Gastroenterology, Urology	1	2025-06-02
HIH	Hysteroscope (And Accessories)	Class II	Obstetrics/Gynecology	1	2024-08-16
FAJ	Cystoscope And Accessories, Flexible/Rigid	Class II	Gastroenterology, Urology	1	2024-06-10

Filings

All 510(k) clearances (7)

Date	K-number	Device	Code	Class	Specialty
2026-07-20	K260516	BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)	FGB	—	—
2026-04-08	K260420	LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)	EOQ	Class II	Ear, Nose, Throat
2025-06-02	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	Class II	Gastroenterology, Urology
2024-08-16	K240978	SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)	HIH	Class II	Obstetrics/Gynecology
2024-06-10	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	Class II	Gastroenterology, Urology
2024-04-05	K233779	LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)	EOQ	Class II	Ear, Nose, Throat
2024-01-11	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	—	—