FDA.reportPublic FDA data

510(k) K153364

Device
Kerecis SecureMesh
Applicant
Kerecis Limited
510(k) number
K153364
Product code
OXE  
Decision
Substantially Equivalent (SESE)
Decision date
2016-08-19
Date received
2015-11-20
Regulation
878.3300
Classification name
Mesh, Surgical, Collagen, Staple Line Reinforcement
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gudmundur Fertram Sigurjonsson
Address
Eyrargata 2 Isafjordur IS 400 400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OXE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated2017-04-28
K030879VERITAS COLLAGEN MATRIXSynovis Surgical Innovations2003-04-24
K022044SURGISIS STAPLE LINE REINFORCEMENTCook Biotech, Inc.2002-08-23

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases