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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 K190194
Device Name C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
Applicant
Pentax Medical, A Division of Pentax of America, Inc.
303 Convention Way, Suite 1
Redwood, Ca,  CA  94063
Applicant Contact Gurvinder Singh Nanda
Correspondent
Pentax Medical, A Division of Pentax of America, Inc.
303 Convention Way, Suite 1
Redwood, Ca,  CA  94063
Correspondent Contact Gurvinder Singh Nanda
Regulation Number878.4350
Classification Product Code
GEH  
Date Received02/04/2019
Decision Date 05/31/2019
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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