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FDA 510(k)

BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215

K-Number: K082941 · 2009-01-07

ApplicantBiomerix Corporation
Decision Date2009-01-07
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 is the device name listed in this FDA 510(k) record. The listed applicant is Biomerix Corporation. It received FDA 510(k) clearance on 2009-01-07 under 510(k) number K082941. 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, MODEL SMNR-0510 AND SMNR-1215?

BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 is a medical device that received FDA 510(k) clearance on 2009-01-07. The listed applicant is Biomerix Corporation. The 510(k) number is K082941.

When did BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 receive FDA 510(k) clearance?

BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 received FDA 510(k) clearance on 2009-01-07, under 510(k) number K082941.

Who is the listed applicant for BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215?

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, MODEL SMNR-0510 AND SMNR-1215?

The FDA product code for BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 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.

K112567BIOMERIX ASSUREK112499BIOMERIX COMPOSITE SURGICAL MESHK093123BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TABK070961BIOMERIX 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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