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510(k) K202430

Device
Kerecis Reconstruct
Applicant
Kerecis Limited
510(k) number
K202430
Product code
OXH  
Decision
Substantially Equivalent (SESE)
Decision date
2021-05-02
Date received
2020-08-25
Regulation
878.3300
Classification name
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
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 – P.O. Box 151 Isafjordur IS 400 400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OXH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251844Kerecis SurgiBind (50241)Kerecis Limited2025-07-15
K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)2017-06-07
K160400Miromatrix Biological MeshMiromatrix Medical, Inc.2016-06-08
K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc.2015-05-12

Legacy Summary#

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FDA Review#

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