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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 K173316
Device Name SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device
Applicant
Transmed7, LLC
117 Solana Rd.
Portola Valley,  CA  94028
Applicant Contact James Vetter
Correspondent
Transmed7, LLC
117 Solana Rd.
Portola Valley,  CA  94028
Correspondent Contact James Vetter
Regulation Number876.1075
Classification Product Code
KNW  
Date Received10/19/2017
Decision Date 06/19/2018
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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