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Found 4 results
510(k) Data Aggregation
K Number
K081327Device Name
RELIMESH
Manufacturer
HERNIAMESH S.R.L.
Date Cleared
2008-06-19
(38 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
HERNIAMESH S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects
Device Description
Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side.
Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer
These meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.
The devices are supplied as sterile, single-use surgical meshes.
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K Number
K050516Device Name
T-SLING
Manufacturer
HERNIAMESH S.R.L.
Date Cleared
2006-02-03
(339 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
HERNIAMESH S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T-Sling is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.
The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Device Description
The T-Sling is made of monofilament polypropylene warp knitted into composite mesh construction. The T-Sling is a sterile, single-use pubourethral sling for the treatment of stress urinary incontinence (SUI).
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K Number
K020652Device Name
HERNIAMESH T-SLING
Manufacturer
HERNIAMESH
Date Cleared
2002-05-15
(76 days)
Product Code
PAH
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
HERNIAMESH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Herniamesh T-sling is a dual-component pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description
Pre-shaped Duel-component mesh Polypropylene and bioabsorbable polymer
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K Number
K973955Device Name
HERNIAMESH SURGICAL MESHES
Manufacturer
HERNIAMESH
Date Cleared
1998-05-11
(207 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
HERNIAMESH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All meshes made by Hemiamesh are made of monofilament polypropylene. The meshes are designed to be used in the surgical repair of abdominal wall hernias such as primary or recurrent inguinal hernias, femoral hernias, inscisional hernias as well as thoracic wall defects.
Device Description
Herniamesh products Hertra 1. 2 & 2A and Hermesh 3, 4 & 5 have the same intended uses as Trelex Mesh and Marlex Mesh. All are used in the repair of primary or recurrent inguinal hernias (particularly when facial structures are weak), primary or recurrent inscisional hernias so large that the fascial edges of the hernial ring cannot be approximated (generally one-fourth of the abdominal wall), femoral hernias, or chest wall defects where it is not possible to use autogenous tissue to prevent or correct lung herniation.
Herniamesh Plugs T1, T2 & T3 have the same intended use as the Marlex Mesh Dart which is used for the repair of hernias with a three dimensional shape i.e. femoral, inguinocrueal or large recurrent inguinal hernias.
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