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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 the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2025-07-15 under 510(k) 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. The listed applicant is Kerecis Limited. The 510(k) number is K251844.

When did Kerecis SurgiBind (50241) receive FDA 510(k) clearance?

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

Who is the listed applicant for Kerecis SurgiBind (50241)?

The FDA 510(k) record lists Kerecis Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Kerecis Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusK243843Tendon Protect (50242)K241080Kerecis Parvus (50207)K213904Kerecis OralK213231Kerecis SiliconeK202430Kerecis Reconstruct

View all 10 devices →

Related Devices (Code: OXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202430Kerecis ReconstructKerecis LimitedK171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)K160400Miromatrix Biological MeshMiromatrix Medical, Inc.

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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