FDA 510(k) Application Details - DEN110016

Device Classification Name

  More FDA Info for this Device
510(K) Number DEN110016
Device Name PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
Applicant ETHICON ENDO-SURGERY
4545 CREEK RD.
CINCINNATI, OH 45242 US
Other 510(k) Applications for this Company
Contact THOMAS BOSTICCO
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 09/21/2011
Decision Date 04/30/2012
Decision DENG -
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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