FDA 510(k) Application Details - K233115

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K233115
Device Name	Arthroscope
Applicant	E Surgical, LLC 150 Isidor Court Suite 203 Sparks, NV 89441 US Other 510(k) Applications for this Company
Contact	Michael Blomeyer Other 510(k) Applications for this Contact
Regulation Number	888.1100   More FDA Info for this Regulation Number
Classification Product Code	HRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2023
Decision Date	02/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review