Class Class II

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) (K240978)

K240978 2024-08-16 Traditional
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Description

SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) by MacroLux Medical Technology Co., Ltd. — FDA 510(k) cleared obstetrics/gynecology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240978
Clearance Date2024-08-16
Clearance TypeTraditional
Product CodeHIH
Regulation Number884.1690

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