510(k) K253404
K253404 is an FDA 510(k) premarket notification submitted by Insera Therapeutics, Inc. for the device "CLEAR Aspiration System". The FDA issued a decision of Substantially Equivalent on Jun 24, 2026.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 24, 2026
- Date Received
- Sep 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No