iotaSOFT Insertion System - Drive Unit, Controller and Accessories
FDA 510(k) clearance DEN190055 · decided 2021-10-01
Clearance details
- K-number
- DEN190055
- Device name
- iotaSOFT Insertion System - Drive Unit, Controller and Accessories
- Applicant
- Iotamotion, Inc.
- Decision
- Unknown
- Date received
- 2019-12-18
- Decision date
- 2021-10-01
- Days to decision
- 653 days
- Clearance type
- Direct
- Product code
- QQH
- Device class
- 2
- Regulation number
- 874.4450
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Iowa City, IA, 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 (K252339) | Iotamotion, Inc. | 2026-01-09 |
Recalls involving this device
No recalls on record reference this clearance.