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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K233675
Device Name FMS VUE™ Fluid Management and Tissue Debridement System
Applicant
DePuy Mitek, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Pol Fort Grebol
Correspondent
DePuy Mitek, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Pol Fort Grebol
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/16/2023
Decision Date 02/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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