FDA 510(k) Application Details - K222575

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K222575
Device Name	Laparoscope, General & Plastic Surgery
Applicant	ThermaSolutions LLC 1889 Buerkle Road St. Paul, MN 55110 US Other 510(k) Applications for this Company
Contact	Gregg Giza Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2022
Decision Date	12/06/2022
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