Kerecis Reconstruct
K-Number: K202430 · 2021-05-02
ApplicantKerecis Limited
Decision Date2021-05-02
Product CodeOXH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Kerecis Reconstruct is a medical device manufactured by Kerecis Limited. It received FDA 510(k) clearance on 2021-05-02 under approval number K202430. The device is classified under product code OXH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Kerecis Reconstruct?
Kerecis Reconstruct is a medical device that received FDA 510(k) clearance on 2021-05-02. It is manufactured by Kerecis Limited. The 510(k) number is K202430.
When was Kerecis Reconstruct approved by the FDA?
Kerecis Reconstruct received FDA 510(k) clearance on 2021-05-02, under approval number K202430.
What company makes Kerecis Reconstruct?
Kerecis Reconstruct is manufactured by Kerecis Limited.
What is the FDA product code for Kerecis Reconstruct?
The FDA product code for Kerecis Reconstruct is OXH.
Other Devices by Kerecis Limited
Related Devices (Code: OXH)
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.