FDA 510(k)

TIO2MESH TM

K-Number: K113311 · 2012-07-17

Decision Date2012-07-17

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TIO2MESH TM is the device name listed in this FDA 510(k) record. The listed applicant is Biocer Entwicklungs GmbH. It received FDA 510(k) clearance on 2012-07-17 under 510(k) number K113311. 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 TIO2MESH TM?

TIO2MESH TM is a medical device that received FDA 510(k) clearance on 2012-07-17. The listed applicant is Biocer Entwicklungs GmbH. The 510(k) number is K113311.

When did TIO2MESH TM receive FDA 510(k) clearance?

TIO2MESH TM received FDA 510(k) clearance on 2012-07-17, under 510(k) number K113311.

Who is the listed applicant for TIO2MESH TM?

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

What is the FDA product code for TIO2MESH TM?

The FDA product code for TIO2MESH TM is FTL.

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 Production K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production K250098Bard 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.