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510(k) Data Aggregation
K Number
K031225Device Name
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
Manufacturer
GFE MEDIZINTECHNIK GMBH
Date Cleared
2003-09-29
(165 days)
Product Code
FTL, OXJ
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
GFE MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TiMESH is intended for the reinforcement of tissue during surgical repair. Specifically, the TiMESH is indicated for laparoscopic and open surgery for the repair of direct inguinal hernias, indirect inguinal hernias, femoral hernias, umbilical hernias, incisional hernias, parietal reinforcement of tissues and abdominal wall repair.
Device Description
TiMESH, also known as TiMESH-TC, hereinafter known as TiMESH/TiMESH-TC" is a non-absorbable polypropylene mesh constructed of warp knitted fabric made from monofilament polypropylene fibers with all around proprietary coating. The TiMESH is constructed using a warp-knit (not woven, not knitted) process. This construction along with the proprietary coating allows the TiMESH to have the strength, flexibility, as well as durability and surgical adaptability to allow for necessary tissue ingrowth. The TiMESH with its current construction provides for elasticity in all directions. The construction of the mesh permits the use of any size mesh without it's unraveling. The wetability allows for the proper adaptation of the mesh to various stresses that can be encountered in the body. The product is stenlized by using ethylene oxide gas.
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