FDA 510(k) Application Details - K220595

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K220595
Device Name	Instrument, Biopsy
Applicant	NeoDynamics AB Lejonvagen 14 Lidingo SE-181 32 SE Other 510(k) Applications for this Company
Contact	Anna Forsberg 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	03/01/2022
Decision Date	09/08/2022
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