iotaSOFT® Insertion System— 510(k) K252339

Substantially Equivalent

Iotamotion, Inc.

FDA 510(k) clearance K252339 for iotaSOFT® Insertion System, Substantially Equivalent on 2026-01-09. Applicant: Iotamotion, Inc..

Clearance details

Applicant: Iotamotion, Inc.
Product code: Code QQH
Advisory panel: Ear, Nose, Throat
Date received: 2025-07-28
Decision date: 2026-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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