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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 ultraviolet light-based microbial reduction device for luer-activated valves
De Novo Number DEN250004
Device Name QIKCAP System
Requester
hai solutions
1902 wright place
suite 200
carlsbad,  CA  92008
Contact brittany batts
Regulation Number880.6512
Classification Product Code
SGX  
Date Received01/30/2025
Decision Date 12/23/2025
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-