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510(k) Data Aggregation
K Number
K092207Device Name
RESTORELLE POLYPROPYLENE MESH
Manufacturer
MPATHY MEDICAL DEVICES INC
Date Cleared
2009-08-04
(13 days)
Product Code
OTP, OTO
Regulation Number
884.5980Why did this record match?
Applicant Name (Manufacturer) :
MPATHY MEDICAL DEVICES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Device Description
Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene.
Restorelle™ polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling.
It maintains excellent isotropic properties arising from its knitted construction.
Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body.
The device is supplied sterile.
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