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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Rigid
510(k) Number K203226
Device Name TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM
Applicant
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Applicant Contact Michael Loiterman
Correspondent
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact Michael Loiterman
Regulation Number876.1500
Classification Product Code
GCM  
Subsequent Product Codes
GCJ   HET  
Date Received11/02/2020
Decision Date 05/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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