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 Stent, Ureteral
510(k) Number K190659
Device Name Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
Applicant
Allwin Medical Devices, Inc.
3305 E. Mira Loma Avenue, Suite 176
Anaheim,  CA  92806
Applicant Contact Digish Mehta
Correspondent
Allwin Medical Devices, Inc.
3305 E. Mira Loma Avenue, Suite 176
Anaheim,  CA  92806
Correspondent Contact Digish Mehta
Regulation Number876.4620
Classification Product Code
FAD  
Date Received03/14/2019
Decision Date 12/02/2019
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-