• 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 instrument, ent manual surgical
510(k) Number K212774
Device Name VenSure LightGuide
Intersect ENT
1555 Adams Dr.
Menlo Park,  CA  94025
Applicant Contact Yoko Enrile
Intersect ENT
1555 Adams Dr.
Menlo Park,  CA  94025
Correspondent Contact Yoko Enrile
Regulation Number874.4420
Classification Product Code
Date Received09/01/2021
Decision Date 02/04/2022
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