FDA 510(k) Application Details - K240664

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K240664
Device Name	Instrument, Biopsy
Applicant	SurGenTec, LLC 911 Clint More Rd Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Guilherme Pires Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2024
Decision Date	08/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review