• 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 staple, implantable
510(k) Number K201280
Device Name Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
Ethicon Endo-Surgery LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Nathan Anderson
Ethicon Endo-Surgery, LLC
4545 Creek Road
Cincinnati,  OH  45242
Correspondent Contact Rubina Dosani
Regulation Number878.4750
Classification Product Code
Date Received05/13/2020
Decision Date 07/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No