510(k) clearances

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

MacroLux Medical Technology Co., Ltd. · Gastroenterology, Urology

K260516Substantially EquivalentTraditionalFGB
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Gastroenterology, Urology
Address 1
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Statement or summary
Summary
Product code
FGB
Zip code
518107
Applicant
MacroLux Medical Technology Co., Ltd.
Decision date
2026-07-20
Decision code
SESE
Country code
CN
Device name
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
Advisory committee
GU
Contact
Ye Linbin
K number
K260516
Date received
2026-02-17
Review advisory committee
GU
Postal code
518107
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Ureteroscope And Accessories, Flexible/Rigid
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
3017425975, 8043903, 3014683069, 3013992977, 3013247477, 3017210488, 3005580113, 3011986317, 3032959393, 3014893827, 3010220595, 1000121056, 3012797688, 9616693, 3021246306, 3004040397, 3004111573, 3014644276, 1418479, 1820334, 3010421104, 3021031769, 3025349506, 3032429484, 3022106566, 3012322232, 3020746799, 3037966040, 2936485, 3004361445, 2531475, 3017367014, 3012843412, 3015139943, 3003206812, 9610773, 3008776287, 3042940358, 3002808148, 9610595 +81 more
FEI number
3014683069, 3013992977, 3002808273, 3013247477, 3017210488, 3005580113, 3003922255, 3011986317, 3032959393, 3014893827, 3010220595, 1000121056, 3012797688, 3021246306, 3008185830, 3004040397, 3004111573, 1418479, 1820334, 3010421104, 3021031769, 3025349506, 3032429484, 3022106566, 3012322232, 3020746799, 3037966040, 2936485, 3004361445, 3017367014, 3006149253, 3015139943, 3012843412, 3003206812, 3006759904, 3008776287, 3002808268, 3007475226, 3002806565, 3002808148 +81 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.