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 endoscopic access overtube, gastroenterology-urology
510(k) Number K211301
Device Name Pathfinder Endoscope Overtube
Applicant
Neptune Medical, Inc.
1828 El Camino Real
Burlingame,  CA  94010
Applicant Contact Alex Tilson
Correspondent
AlvaMed, Inc.
935 Great Plain Ave, Ste 166
Needham,  MA  02492
Correspondent Contact Ian Broome
Regulation Number876.1500
Classification Product Code
FED  
Date Received04/29/2021
Decision Date 05/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-