ClearUP Sinus Relief
FDA 510(k) clearance DEN200006 · decided 2021-03-05
Clearance details
- K-number
- DEN200006
- Device name
- ClearUP Sinus Relief
- Applicant
- Tivic Health Systems, Inc.
- Decision
- Unknown
- Date received
- 2020-02-07
- Decision date
- 2021-03-05
- Days to decision
- 392 days
- Clearance type
- Direct
- Product code
- QNU
- Device class
- 2
- Regulation number
- 874.6000
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.