CLEAR™ Aspiration System
FDA 510(k) clearance K253404 · decided 2026-06-24
Clearance details
- K-number
- K253404
- Device name
- CLEAR™ Aspiration System
- Applicant
- Insera Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-30
- Decision date
- 2026-06-24
- Days to decision
- 267 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.