510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253404Substantially Equivalent

CLEAR™ Aspiration System

Insera Therapeutics, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253404 is the FDA 510(k) clearance record for CLEAR™ Aspiration System, cleared for Insera Therapeutics, Inc. on . FDA records list one 510(k) clearance for Insera Therapeutics, Inc. As of , FDA records show no recalls naming K253404.

Clearance record

Decision date
Received
(267 days to decision)
Review panel
Unknown
Applicant
Insera Therapeutics, Inc. 5546 Serrano Ave., Dallas TX
510(k) summary
Summary PDF
Third party review
No