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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K182664
Device Name FiXcision
Applicant
Agency For Medical Innovations GmbH
Im Letten 1
Feldkirch,  AT 6800
Applicant Contact Martin Hohlrieder
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison C. Komiyama
Regulation Number876.4730
Classification Product Code
KOA  
Date Received09/25/2018
Decision Date 12/07/2018
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
Predetermined Change
Control Plan Authorized		 No
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