Class Class I

Heylo™ System (K252140)

K252140 2025-10-06 Traditional
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Description

Heylo™ System by Coloplast Corp., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK252140
Clearance Date2025-10-06
Clearance TypeTraditional
Product CodeEXB
Regulation Number876.5900

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