Portare System (FA-001)— 510(k) K243639
Substantially EquivalentGrumpy Innovation, Inc.
FDA 510(k) clearance K243639 for Portare System (FA-001), Substantially Equivalent on 2025-06-05. Applicant: Grumpy Innovation, Inc.. Device class: 2.
Clearance details
- Applicant
- Grumpy Innovation, Inc.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sioux Falls, SD, US
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Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.