Class Class II

Kii Structural Balloon Access System (K252442)

K252442 2025-10-31 Traditional
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Description

Kii Structural Balloon Access System by Applied Medical Resources Corp., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252442
Clearance Date2025-10-31
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500

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