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FDA 510(k)

SERI SURGICAL SCAFFOLD

K-Number: K123128 · 2013-04-25

ApplicantAllergan
Decision Date2013-04-25
Product CodeOXF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERI SURGICAL SCAFFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Allergan. It received FDA 510(k) clearance on 2013-04-25 under 510(k) number K123128. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERI SURGICAL SCAFFOLD?

SERI SURGICAL SCAFFOLD is a medical device that received FDA 510(k) clearance on 2013-04-25. The listed applicant is Allergan. The 510(k) number is K123128.

When did SERI SURGICAL SCAFFOLD receive FDA 510(k) clearance?

SERI SURGICAL SCAFFOLD received FDA 510(k) clearance on 2013-04-25, under 510(k) number K123128.

Who is the listed applicant for SERI SURGICAL SCAFFOLD?

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

What is the FDA product code for SERI SURGICAL SCAFFOLD?

The FDA product code for SERI SURGICAL SCAFFOLD is OXF.

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Related Devices (Code: OXF)

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.

K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.K2326023DMatrix Surgical MeshPrintbio, Inc.K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.K172545SERI ContourSofregen Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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