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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K201526
Device Name TIPCAM1 Rubina Video Endoscope System
Applicant
Karl Storz Endoscopy America
2151 E. Grand Ave.
El Segundo,  CA  90245
Applicant Contact Mario Trujillo
Correspondent
Karl Storz Endoscopy America
2151 E. Grand Ave.
El Segundo,  CA  90245
Correspondent Contact Mario Trujillo
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
FGB   HET  
Date Received06/08/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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