K243639
- 510(k) number
- K243639
- Device name
- Portare System (FA-001)
- Applicant
- Grumpy Innovation, Inc. SD · US
- Product code
- EOB — Nasopharyngoscope (Flexible Or Rigid)
- Decision date
- 2025-06-05
- Date received
- 2024-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243639.pdf
Official FDA record: K243639
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.