Portare System (FA-001)
FDA 510(k) clearance K243639 · decided 2025-06-05
Clearance details
- K-number
- K243639
- Device name
- Portare System (FA-001)
- Applicant
- Grumpy Innovation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-25
- Decision date
- 2025-06-05
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Sioux Falls, SD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.