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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Morcellator Gastroenterology
510(k) Number K170120
Device Name EndoRotor
Applicant
Interscope, Inc.
100 Grove St., Suite 108
Worchester,  MA  01605
Applicant Contact Jeffrey Ryan
Correspondent
Icon Clinical Research, LLC
2100 Pennbrook Pkwy.
Marlborough,  PA  19454
Correspondent Contact Cynthia Nolte
Regulation Number884.1690
Classification Product Code
PTE  
Date Received01/13/2017
Decision Date 04/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
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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