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510(k) K240776

Celsio Flexible Cryocatheter System by Endocision Technologies, Inc. — Product Code GEH

K240776 is an FDA 510(k) premarket notification submitted by Endocision Technologies, Inc. for the device "Celsio Flexible Cryocatheter System". The FDA issued a decision of Substantially Equivalent on Sep 24, 2024. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 24, 2024
Date Received
Mar 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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FDA data resources