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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K190378
Device Name Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
Applicant
Bioncise NV
Bodemstraat 16
Wellen,  BE 3500
Applicant Contact Jaak Janssens
Correspondent
Bioncise NV
Bodemstraat 16
Wellen,  BE 3830
Correspondent Contact Jaak Janssens
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Codes
HCZ   HHK  
Date Received02/19/2019
Decision Date 05/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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