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FDA 510(k)

Kerecis SurgiBind (50241)

K-Number: K251844 · 2025-07-15

ApplicantKerecis Limited
Decision Date2025-07-15
Product CodeOXH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kerecis SurgiBind (50241) is a medical device manufactured by Kerecis Limited. It received FDA 510(k) clearance on 2025-07-15 under approval number K251844. 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 SurgiBind (50241)?

Kerecis SurgiBind (50241) is a medical device that received FDA 510(k) clearance on 2025-07-15. It is manufactured by Kerecis Limited. The 510(k) number is K251844.

When was Kerecis SurgiBind (50241) approved by the FDA?

Kerecis SurgiBind (50241) received FDA 510(k) clearance on 2025-07-15, under approval number K251844.

What company makes Kerecis SurgiBind (50241)?

Kerecis SurgiBind (50241) is manufactured by Kerecis Limited.

What is the FDA product code for Kerecis SurgiBind (50241)?

The FDA product code for Kerecis SurgiBind (50241) is OXH.

Other Devices by Kerecis Limited

K153364Kerecis SecureMesh K190528MariGen Wound Extra K192612Kerecis Gingiva Graft K202430Kerecis Reconstruct K213231Kerecis Silicone K241080Kerecis Parvus (50207)

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Related Devices (Code: OXH)

K160400Miromatrix Biological MeshMiromatrix Medical, Inc. K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences) K202430Kerecis ReconstructKerecis Limited

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.

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