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 electrode, electrosurgical, active, urological
510(k) Number K961702
Device Name KSEA VAPORIZATION ELECTRODES
Applicant
KARL STORZ ENDOSKOP GMBH
600 CORPORATE POINTE
CULVER CITY,  CA  90230
Applicant Contact BETTY M JOHNSON
Correspondent
KARL STORZ ENDOSKOP GMBH
600 CORPORATE POINTE
CULVER CITY,  CA  90230
Correspondent Contact BETTY M JOHNSON
Regulation Number876.4300
Classification Product Code
FAS  
Date Received05/02/1996
Decision Date 08/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-