Class Class II

iotaSOFT® Insertion System (K252339)

K252339 2026-01-09 Traditional
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Description

iotaSOFT® Insertion System by Iotamotion, Inc., an FDA 510(k) cleared ear, nose, throat device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252339
Clearance Date2026-01-09
Clearance TypeTraditional
Product CodeQQH
Regulation Number874.4450

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