FDA 510(k) Application Details - K230535

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K230535
Device Name	Powered Laser Surgical Instrument
Applicant	Karl Storz SE & CO. KG Dr.-Karl-Storz-Stra▀e 34 Baden-Wurttemberg Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Alita McElroy Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2023
Decision Date	09/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review