meddevicedb.com FDA Device Reference

iotaSOFT Insertion System - Drive Unit, Controller and Accessories

DEN190055 Class II Direct
Decision Date
2021-10-01
Sponsor / Applicant
Iotamotion, Inc.

Technical Specification

510(k) Submission ID DEN190055
Product Code QQH
Medical Specialty / Panel Ear, Nose, Throat
Regulation Citation 21 CFR 874.4450
Decision Date 2021-10-01
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

iotaSOFT Insertion System - Drive Unit, Controller and Accessories received FDA 510(k) clearance under submission number DEN190055, sponsored by Iotamotion, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2021-10-01.

Classification & Regulation

This clearance is catalogued under FDA product code QQH and 21 CFR 874.4450, within the Ear, Nose, Throat review panel as a Class II device.