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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 the device name listed in this FDA 510(k) record. The listed applicant is Iotamotion, Inc.. It received FDA 510(k) clearance on 2026-01-09 under 510(k) 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. The listed applicant is Iotamotion, Inc.. The 510(k) number is K252339.

When did iotaSOFT® Insertion System receive FDA 510(k) clearance?

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

Who is the listed applicant for iotaSOFT® Insertion System?

The FDA 510(k) record lists Iotamotion, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06106373iotaSOFT Pediatric StudyCOMPLETED

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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