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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 K241990
Device Name SpineSite Endoscope System
Applicant
Hydrocision, Inc.
267 Boston Rd.
Suite 28
North Billerica,  MA  01862
Applicant Contact Mark Lewis
Correspondent
Hydrocision, Inc.
267 Boston Rd.
Suite 28
North Billerica,  MA  01862
Correspondent Contact Mark Lewis
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/08/2024
Decision Date 07/30/2025
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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