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FDA 510(k)

BIOMERIX COMPOSITE SURGICAL MESH

K-Number: K112499 · 2011-12-23

ApplicantBiomerix Corporation
Decision Date2011-12-23
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOMERIX COMPOSITE SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Biomerix Corporation. It received FDA 510(k) clearance on 2011-12-23 under 510(k) number K112499. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMERIX COMPOSITE SURGICAL MESH?

BIOMERIX COMPOSITE SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2011-12-23. The listed applicant is Biomerix Corporation. The 510(k) number is K112499.

When did BIOMERIX COMPOSITE SURGICAL MESH receive FDA 510(k) clearance?

BIOMERIX COMPOSITE SURGICAL MESH received FDA 510(k) clearance on 2011-12-23, under 510(k) number K112499.

Who is the listed applicant for BIOMERIX COMPOSITE SURGICAL MESH?

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

What is the FDA product code for BIOMERIX COMPOSITE SURGICAL MESH?

The FDA product code for BIOMERIX COMPOSITE SURGICAL MESH is FTL.

Related Clinical Trials

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Other records listing Biomerix Corporation 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.

K112567BIOMERIX ASSUREK093123BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TABK082941BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215K070961BIOMERIX SURGICAL MESH, MODEL: RCR-01K043371BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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