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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 K150127
Device Name Laparoscopic Handles with peek Insulation
Applicant
Stryker Endoscopy
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Rebecca Goldberg
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plz., Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/20/2015
Decision Date 02/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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