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 electrosurgical, cutting & coagulation & accessories
510(k) Number K041285
Device Name GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
Applicant
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF,  GB CF3 0LT
Applicant Contact ANDREW DZIMITROWICZ
Correspondent
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF,  GB CF3 0LT
Correspondent Contact ANDREW DZIMITROWICZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/13/2004
Decision Date 09/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-