CLEAR Aspiration System— 510(k) K253404
Substantially EquivalentInsera Therapeutics, Inc.
FDA 510(k) clearance K253404 for CLEAR Aspiration System, Substantially Equivalent on 2026-06-24. Applicant: Insera Therapeutics, Inc..
Summary
The CLEAR Aspiration System is from Insera Therapeutics. This record gives no product code, device class, or regulation number, and it doesn't describe the system beyond its name.
The classification panel is listed as Unknown, and the Cardiovascular review panel handled it as a Traditional 510(k).
Insera filed from Dallas, Texas. Review took 267 calendar days (September 30, 2025 to June 24, 2026).
Clearance details
- Applicant
- Insera Therapeutics, Inc.
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.