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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 K180134
Device Name Ensizor Monopolar Endoscopic Scissors
Applicant
Slater Endoscopy, LLC
14000 NW 58 Ct.
Miami Lakes,  FL  33014
Applicant Contact John Starkey
Correspondent
C2c Development, LLC
1135 W Nasa Blvd., Suite 500
Melbourne,  FL  32901
Correspondent Contact Craig Pagan
Regulation Number876.4300
Classification Product Code
KGE  
Subsequent Product Code
OCZ  
Date Received01/17/2018
Decision Date 06/29/2018
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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