FDA 510(k) Application Details - K200841

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

  More FDA Info for this Device
510(K) Number K200841
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Ethicon Endo-Surgery, Llc
475 Calle C
Guaynabo, PR 00969 US
Other 510(k) Applications for this Company
Contact Nathan Anderson
Other 510(k) Applications for this Contact
Regulation Number 878.4400

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

  More FDA Info for this Product Code
Date Received 03/31/2020
Decision Date 05/11/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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