FDA 510(k) Application Details - K243602

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K243602
Device Name	Arthroscope
Applicant	Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108 US Other 510(k) Applications for this Company
Contact	Lai Saeteurn 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	11/21/2024
Decision Date	05/16/2025
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