FDA 510(k) Application Details - K242983

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K242983
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Creo Medical Ltd Unit 2 Beaufort Park Beaufort Park Way Chepstow NP16 5UH GB Other 510(k) Applications for this Company
Contact	Diane Davis Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2024
Decision Date	02/05/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review