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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 K200228
Device Name ClearCam System
Applicant
ClearCam, LLC
1601 Trinity St., Bldg B M/S Z-1400
Austin,  TX  78712
Applicant Contact Chris Idelson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/30/2020
Decision Date 02/19/2020
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
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