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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 K100533
Device Name VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,
Applicant
Vibrynt, Inc.
701-A Galveston Dr.
Redwood City,  CA  94063
Applicant Contact JULIA S ANASTAS
Correspondent
Vibrynt, Inc.
701-A Galveston Dr.
Redwood City,  CA  94063
Correspondent Contact JULIA S ANASTAS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/25/2010
Decision Date 02/08/2011
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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