Kerecis SecureMesh
K-Number: K153364 · 2016-08-19
ApplicantKerecis Limited
Decision Date2016-08-19
Product CodeOXE
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Kerecis SecureMesh is a medical device manufactured by Kerecis Limited. It received FDA 510(k) clearance on 2016-08-19 under approval number K153364. The device is classified under product code OXE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Kerecis SecureMesh?
Kerecis SecureMesh is a medical device that received FDA 510(k) clearance on 2016-08-19. It is manufactured by Kerecis Limited. The 510(k) number is K153364.
When was Kerecis SecureMesh approved by the FDA?
Kerecis SecureMesh received FDA 510(k) clearance on 2016-08-19, under approval number K153364.
What company makes Kerecis SecureMesh?
Kerecis SecureMesh is manufactured by Kerecis Limited.
What is the FDA product code for Kerecis SecureMesh?
The FDA product code for Kerecis SecureMesh is OXE.
Other Devices by Kerecis Limited
Related Devices (Code: OXE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.