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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K142258
Device Name PolyCatch Retrieval Device
Applicant
Medi-Globe Corporation
110 West Orion Street
Tempe,  AZ  85283
Applicant Contact Scott Karler
Correspondent
Medi-Globe Corporation
110 West Orion Street
Tempe,  AZ  85283
Correspondent Contact Scott Karler
Regulation Number876.4300
Classification Product Code
FDI  
Date Received08/14/2014
Decision Date 09/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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