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FDA 510(k)

LTM-T SURGICAL MESH

K-Number: K080353 · 2008-04-03

ApplicantLifecell Corp.
Decision Date2008-04-03
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LTM-T SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corp.. It received FDA 510(k) clearance on 2008-04-03 under 510(k) number K080353. 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 LTM-T SURGICAL MESH?

LTM-T SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2008-04-03. The listed applicant is Lifecell Corp.. The 510(k) number is K080353.

When did LTM-T SURGICAL MESH receive FDA 510(k) clearance?

LTM-T SURGICAL MESH received FDA 510(k) clearance on 2008-04-03, under 510(k) number K080353.

Who is the listed applicant for LTM-T SURGICAL MESH?

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

What is the FDA product code for LTM-T SURGICAL MESH?

The FDA product code for LTM-T SURGICAL MESH is FTL.

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Other records listing Lifecell Corp. 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.

K130817LTN - LAPAROSCOPIC SURGICAL MESHK112534LIFECELL TISSUE EXPANDERK121289LTM-LABAROSCOPIC SURGICAL MESHK082176LTM-BPS SURGICAL MESHK082103LTM WOUND DRESSINGK071986LTM-RC SURGICAL MESH

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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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