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FDA 510(k)

PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX

K-Number: K111436 · 2011-10-14

ApplicantBrennen Medical, LLC
Decision Date2011-10-14
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Brennen Medical, LLC. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K111436. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX?

PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Brennen Medical, LLC. The 510(k) number is K111436.

When did PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX receive FDA 510(k) clearance?

PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX received FDA 510(k) clearance on 2011-10-14, under 510(k) number K111436.

Who is the listed applicant for PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX?

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

What is the FDA product code for PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX?

The FDA product code for PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX is FTM.

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Other records listing Brennen Medical, LLC 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.

K113866PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIXK081272PORCINE SURGICAL MESH; DERMAL MATRIX

Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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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