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 Endoilluminator
510(k) Number K221872
Device Name ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
Applicant
Nova Eye Inc. (Business Name Nova Eye Medical)
41316 Christy St.
Fremont,  CA  94538
Applicant Contact Don Watton
Correspondent
Eds Regulatory Consulting, Inc.
95 Bryce Run
Lake Forest,  CA  92630
Correspondent Contact Evelyn De La Vega Stewart
Regulation Number876.1500
Classification Product Code
MPA  
Subsequent Product Code
HMX  
Date Received06/28/2022
Decision Date 03/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-