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 tubes, gastrointestinal (and accessories)
510(k) Number K203133
Device Name ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
Applicant
ENvizion Medical Ltd.
7 Haarad St.
Tel Aviv,  IL 6971060
Applicant Contact Doron Besser
Correspondent
Evergreen Research, Inc.
433 Park Point Drive, Suite 140
Golden,  CO  80401
Correspondent Contact John Mann
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
PIF  
Date Received10/19/2020
Decision Date 03/24/2021
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
-
-