K253404
- 510(k) number
- K253404
- Device name
- CLEAR Aspiration System
- Applicant
- Insera Therapeutics, Inc. TX · US
- Decision date
- 2026-06-24
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253404.pdf
Official FDA record: K253404
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.