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 Laparoscope, General & Plastic Surgery, Reprocessed
510(k) Number K160740
Device Name Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
Applicant
Surgical Instrument Service and Savings, Inc.
2747 SW 6th St.
Redmond,  OR  97756
Applicant Contact BRANDI J. PANTELEON
Correspondent
Surgical Instrument Service and Savings, Inc.
2747 SW 6th St.
Redmond,  OR  97756
Correspondent Contact BRANDI J. PANTELEON
Regulation Number876.1500
Classification Product Code
NLM  
Date Received03/17/2016
Decision Date 05/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-