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 Catheter, Retention Type, Balloon
510(k) Number K222118
Device Name 2-Way 100% Silicone Cleartract Catheter
Applicant
SILQ Technologies, Corp.
323 Sunny Isles Blvd., 7th Floor
Sunny Isles Beach,  FL  33160
Applicant Contact D. Verne Sharma
Correspondent
Pathway LLC
8779 Cottonwood Ave, Suite 105
Santee,  CA  92071
Correspondent Contact Aaron Rogers
Regulation Number876.5130
Classification Product Code
EZL  
Date Received07/18/2022
Decision Date 12/01/2022
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
-
-