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FDA 510(k)

iotaSOFT® Insertion System

K-Number: K252339 · 2026-01-09

ApplicantIotamotion, Inc.
Decision Date2026-01-09
Product CodeQQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

iotaSOFT® Insertion System is a medical device manufactured by Iotamotion, Inc.. It received FDA 510(k) clearance on 2026-01-09 under approval number K252339. The device is classified under product code QQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iotaSOFT® Insertion System?

iotaSOFT® Insertion System is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by Iotamotion, Inc.. The 510(k) number is K252339.

When was iotaSOFT® Insertion System approved by the FDA?

iotaSOFT® Insertion System received FDA 510(k) clearance on 2026-01-09, under approval number K252339.

What company makes iotaSOFT® Insertion System?

iotaSOFT® Insertion System is manufactured by Iotamotion, Inc..

What is the FDA product code for iotaSOFT® Insertion System?

The FDA product code for iotaSOFT® Insertion System is QQH.

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Other Devices by Iotamotion, Inc.

DEN190055iotaSOFT Insertion System - Drive Unit, Controller and Accessories

Related Devices (Code: QQH)

DEN190055iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesIotamotion, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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