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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 K183165
Device Name Pristine Scope
Applicant
Pristine Surgical
Brady Sullivan Tower, 6th Floor, 1750 Elm St.
Manchester,  NH  03104
Applicant Contact Stewart B. Davis
Correspondent
Pristine Surgical
Brady Sullivan Tower, 6th Floor, 1750 Elm St.
Manchester,  NH  03104
Correspondent Contact Stewart B. Davis
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/15/2018
Decision Date 01/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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