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 arthroscope
510(k) Number K002437
Device Name ENDIUS ENDOSCOPIC ACCESS SYSTEM
Applicant
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE,  MA  02762
Applicant Contact SUSAN FINNERAN
Correspondent
ENDIUS, INC.
23 WEST BACON ST.
PLAINVILLE,  MA  02762
Correspondent Contact SUSAN FINNERAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/09/2000
Decision Date 10/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-