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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 K242228
Device Name Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
Applicant
Triopsy Medical, Inc.
151 St. Andrews Ct.
Mankato,  MN  56001
Applicant Contact David Bostwick
Correspondent
Eri Group
501 N Ford St.
Golden,  CO  80403
Correspondent Contact John Mann
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received07/30/2024
Decision Date 01/10/2025
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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