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 K050550
Device Name GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
Applicant
Gyrus Medical, Inc.
6655 Wedgwood Rd.
Suite 160
Maple Grove,  MN  55311
Applicant Contact MARK JENSEN
Correspondent
Gyrus Medical, Inc.
6655 Wedgwood Rd.
Suite 160
Maple Grove,  MN  55311
Correspondent Contact MARK JENSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/03/2005
Decision Date 11/09/2005
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
Predetermined Change
Control Plan Authorized		 No
-
-