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
510(k) Number K201805
Device Name VersaOne Reusable Positioning Trocar System
Applicant
Covidien
60 Middletown Avenue
North Haven,  CT  06473
Applicant Contact Stephanie Wilde
Correspondent
Covidien
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Stephanie Wilde
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/01/2020
Decision Date 08/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-