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 K072177
Device Name ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM
Applicant
SURGRX, INC.
101 SAGINAW DR.
REDWOOD CITY,  CA  94063
Applicant Contact LINDA OLESON
Correspondent
SURGRX, INC.
101 SAGINAW DR.
REDWOOD CITY,  CA  94063
Correspondent Contact LINDA OLESON
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HGI  
Date Received08/06/2007
Decision Date 09/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-