Class Class II

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) (K240227)

K240227 2024-08-22 Traditional
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Description

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) by Lina Medical Aps — FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240227
Clearance Date2024-08-22
Clearance TypeTraditional
Product CodeFAJ
Regulation Number876.1500

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