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FDA 510(k)

RELIMESH

K-Number: K081327 · 2008-06-19

ApplicantHerniamesh S.R.L.
Decision Date2008-06-19
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RELIMESH is the device name listed in this FDA 510(k) record. The listed applicant is Herniamesh S.R.L.. It received FDA 510(k) clearance on 2008-06-19 under 510(k) number K081327. 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 RELIMESH?

RELIMESH is a medical device that received FDA 510(k) clearance on 2008-06-19. The listed applicant is Herniamesh S.R.L.. The 510(k) number is K081327.

When did RELIMESH receive FDA 510(k) clearance?

RELIMESH received FDA 510(k) clearance on 2008-06-19, under 510(k) number K081327.

Who is the listed applicant for RELIMESH?

The FDA 510(k) record lists Herniamesh S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RELIMESH?

The FDA product code for RELIMESH is FTL.

Related Clinical Trials

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.

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Other records listing Herniamesh S.R.L. 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.

K050516T-SLING

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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