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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K140378
Device Name FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
Applicant
Omniguide, Inc.
One Kendall Sq.
Suite B1301
Cambridge,  MA  02139
Applicant Contact NICOLE RASMUSSEN
Correspondent
Omniguide, Inc.
One Kendall Sq.
Suite B1301
Cambridge,  MA  02139
Correspondent Contact NICOLE RASMUSSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/14/2014
Decision Date 09/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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