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 Accessories, Catheter, G-U
510(k) Number K123170
Device Name VARI-PASS VARIABLE LENGTH ACCESS SHEATH
Applicant
Olympus Surgical Technologies America
136 Turnpike Rd.
Southborough,  MA  01772
Applicant Contact DEANA BOUSHELL
Correspondent
Olympus Surgical Technologies America
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact DEANA BOUSHELL
Regulation Number876.5130
Classification Product Code
KNY  
Date Received10/09/2012
Decision Date 02/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-