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 Endoscope Channel Accessory
510(k) Number K232327
Device Name Endorail
Applicant
Endostart S.R.L.
Via Delle Regioni 265
Certaldo,  IT 50052
Applicant Contact Alessandro Tozzi
Correspondent
Qa & RA Medical Device Consulting , Ltd.
842 Clarke Rd.
Brentwood Bay,  CA V8M 2G1
Correspondent Contact Fabio De Pasquale
Regulation Number876.1500
Classification Product Code
ODC  
Date Received08/03/2023
Decision Date 03/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05626738
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-