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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 K170084
Device Name InterLock Trocar
Applicant
Fujifilm New Development U.S.A., Inc.
318 Bear Hill Rd., Suite 10
Waltham,  MA  02451
Applicant Contact Stephen Mariano
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/10/2017
Decision Date 03/10/2017
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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