• 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 ear, nose, and throat stereotaxic instrument
510(k) Number K161555
Device Name KARL STORZ NAV1 Electromagnetic Navigation System
Applicant
KARL STORZ Endoscopy America, Inc.
2151 E. Grand Ave
El Segundo,  CA  90245
Applicant Contact Leigh Spotten
Correspondent
KARL STORZ Endoscopy America, Inc.
2151 E. Grand Ave
El Segundo,  CA  90245
Correspondent Contact Leigh Spotten
Regulation Number882.4560
Classification Product Code
PGW  
Date Received06/06/2016
Decision Date 10/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-