• 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 K192330
Device Name EEA Circular Stapler with Tri-Staple Technology
Rooms 501, 502, 601, 602, No.3 building
No.2388 Chen Hang Road
Min Hang District, Shanghai,  CN 201114
Applicant Contact Sarah Tang
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Frank Gianelli
Regulation Number878.4750
Classification Product Code
Date Received08/27/2019
Decision Date 01/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No