FDA 510(k) Application Details - K240776

Device Classification Name	Unit, Cryosurgical, Accessories   More FDA Info for this Device
510(K) Number	K240776
Device Name	Unit, Cryosurgical, Accessories
Applicant	Endocision Technologies Inc. 338 Rue Saint-Antoine Est, Suite 407 Montreal H2Y1A3 CA Other 510(k) Applications for this Company
Contact	Anthony Sirgi Other 510(k) Applications for this Contact
Regulation Number	878.4350   More FDA Info for this Regulation Number
Classification Product Code	GEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2024
Decision Date	09/24/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review