iotaSOFT® Insertion System— 510(k) K252339
Substantially EquivalentIotamotion, Inc.
FDA 510(k) clearance K252339 for iotaSOFT® Insertion System, Substantially Equivalent on 2026-01-09. Applicant: Iotamotion, Inc.. Device class: 2.
Clearance details
- Applicant
- Iotamotion, Inc.
- Product code
- Code QQH
- Device class
- Class 2
- Regulation
- 21 CFR 874.4450
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code QQH
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