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
510(k) Number K161600
Device Name Resection Electrodes
Applicant
OLYMPUS WINTER & IBE GMBH
KUEHNSTRASSE 61
Hamburg,  DE 22045
Applicant Contact Katharina Campbell
Correspondent
GYRUS ACMI, INC.
136 TURNPIKE ROAD
Southborough,  MA  01772
Correspondent Contact Dolan Mills
Regulation Number878.4400
Classification Product Code
JOS  
Subsequent Product Code
HIH  
Date Received06/09/2016
Decision Date 09/06/2016
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
-
-