FDA 510(k) Application Details - K131656

Device Classification Name Laparoscope, Gynecologic (And Accessories)

  More FDA Info for this Device
510(K) Number K131656
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
SOMERVILLE, NJ 08876-0151 US
Other 510(k) Applications for this Company
Contact SARAH MCMANUS
Other 510(k) Applications for this Contact
Regulation Number 884.1720

  More FDA Info for this Regulation Number
Classification Product Code HET
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/06/2013
Decision Date 09/27/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact