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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K240776
Device Name Celsio Flexible Cryocatheter System
Applicant
Endocision Technologies, Inc.
338 Rue Saint-Antoine Est, Suite 407
Montreal,  CA H2Y1A3
Applicant Contact Anthony Sirgi
Correspondent
Endocision Technologies, Inc.
338 Rue Saint-Antoine Est, Suite 407
Montreal,  CA H2Y1A3
Correspondent Contact Anthony Sirgi
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/21/2024
Decision Date 09/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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