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 Prosthesis, Tracheal, Preformed/Molded
510(k) Number K261541
Device Name VisionAir Enhanced Stock Stent
Applicant
VisionAir Solutions
1800 Triplett Blvd.
Akron,  OH  44306
Applicant Contact Jacob Marsh
Correspondent
VisionAir Solutions
1800 Triplett Blvd.
Akron,  OH  44306
Correspondent Contact Jacob Marsh
Regulation Number878.3720
Classification Product Code
NWA  
Date Received05/08/2026
Decision Date 06/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-