Class Class II

Koala Intrauterine Pressure Catheter (IPC-5000E) (K250897)

K250897 2025-05-22 Traditional
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Description

Koala Intrauterine Pressure Catheter (IPC-5000E) by Clinical Innovations, LLC, an FDA 510(k) cleared obstetrics/gynecology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250897
Clearance Date2025-05-22
Clearance TypeTraditional
Product CodeHFN
Regulation Number884.2700

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