Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K201135
Device Name Image1 S CCU, Image1 S 4U Camera Head
Applicant
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact Alita McElroy
Correspondent
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Alita McElroy
Regulation Number876.1500
Classification Product Code
FET  
Date Received04/28/2020
Decision Date 09/01/2020
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
-
-