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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K090583
Device Name ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
Applicant
Apollo Endosurgery, Inc.
7000 Bee Caves Rd.
Suite 350
Austin,  TX  78746
Applicant Contact GREG MATHISON
Correspondent
Apollo Endosurgery, Inc.
7000 Bee Caves Rd.
Suite 350
Austin,  TX  78746
Correspondent Contact GREG MATHISON
Regulation Number876.4300
Classification Product Code
KGE  
Date Received03/04/2009
Decision Date 06/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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