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FDA 510(k)

BIOMERIX ASSURE

K-Number: K112567 · 2011-12-23

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

Device Summary

BIOMERIX ASSURE 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 K112567. 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 ASSURE?

BIOMERIX ASSURE 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 K112567.

When did BIOMERIX ASSURE receive FDA 510(k) clearance?

BIOMERIX ASSURE received FDA 510(k) clearance on 2011-12-23, under 510(k) number K112567.

Who is the listed applicant for BIOMERIX ASSURE?

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 ASSURE?

The FDA product code for BIOMERIX ASSURE is FTL.

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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.

K112499BIOMERIX COMPOSITE SURGICAL MESHK093123BIOMERIX 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

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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