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 Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K241731
Device Name Outlook Surgical Versa One System (8900139)
Applicant
Resnent, LLC
3210 Mulligan Dr.
Bloomington,  IL  61704
Applicant Contact Willard Noyes
Correspondent
Mededge Consulting
7005 Evergreen Pl.
Roswell,  GA  30076
Correspondent Contact Billi-Jo Pfalzgraf
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/17/2024
Decision Date 08/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-