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FDA 510(k)

BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09

K-Number: K093196 · 2010-06-25

ApplicantCousin Biotech Sas
Decision Date2010-06-25
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 is the device name listed in this FDA 510(k) record. The listed applicant is Cousin Biotech Sas. It received FDA 510(k) clearance on 2010-06-25 under 510(k) number K093196. 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 BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09?

BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Cousin Biotech Sas. The 510(k) number is K093196.

When did BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 receive FDA 510(k) clearance?

BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 received FDA 510(k) clearance on 2010-06-25, under 510(k) number K093196.

Who is the listed applicant for BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09?

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

What is the FDA product code for BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09?

The FDA product code for BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 is FTL.

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Other records listing Cousin Biotech Sas 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.

K181086Cortical Fixation SystemsK181799ResCUBE™ Ligament Fixation SystemK172206NAJA™ Ligament Correction SystemK072962CABS'AIR

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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