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 Air Filter Portable Apparatus
510(k) Number K163455
Device Name SurgiCube
Applicant
SURGICUBE INTERNATIONAL B.V.
SEGGELANT-NOORD 4
VIERPOLDERS,  NL 3237 MG
Applicant Contact GER VIJFVINKEL
Correspondent
SURGICUBE INTERNATIONAL B.V.
SEGGELANT-NOORD 4
VIERPOLDERS,  NL 3237 MG
Correspondent Contact GER VIJFVINKEL
Regulation Number878.5070
Classification Product Code
ORC  
Date Received12/09/2016
Decision Date 09/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-