iotaSOFT® Insertion System
FDA 510(k) clearance K252339 · decided 2026-01-09
Clearance details
- K-number
- K252339
- Device name
- iotaSOFT® Insertion System
- Applicant
- Iotamotion, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-28
- Decision date
- 2026-01-09
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- QQH
- Device class
- 2
- Regulation number
- 874.4450
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iotaSOFT Insertion System - Drive Unit, Controller and Accessories (DEN190055) | Iotamotion, Inc. | 2021-10-01 |
Recalls involving this device
No recalls on record reference this clearance.