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510(k) Data Aggregation
K Number
K090432Device Name
HEMORPEX SYSTEM
Manufacturer
Date Cleared
2009-05-29
(99 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLOGICA B. M. SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.
Device Description
HEMORPEX SYSTEM (HPS) is a diagnostic and operating anoscope, which is mainly intended for the surgical treatment of the hemorrhodal disease through dearterializing hemorrhoidopexy. HemorPex System (HPS) is a device made by a fixed part which remains in contact with the anoderma and the sensible mucosa of the anal canal, and by a rotating operative part which includes the window through which the suture stitches are posed. The instrument has 6 preset positions of the operative window. In these positions there are the 6 terminal branches of the superior hemorrhoidal artery.
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K Number
K043191Device Name
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
Manufacturer
Date Cleared
2005-05-16
(180 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ANGIOLOGICA B. M. SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Angimesh Pre: "Repair of inguinal hernia defects."
Folded Mesh: "Repair of inguinal hernia defects."
Repol Plug Basic: "Repair of inguinal hernia defects."
Repol Plug Cap: "Repair of inguinal hernia defects."
Repol Plug Flower: "Repair of inguinal hernia defects."
Repol Angimesh: "To reinforce soft tissue where weakness exists, i.e., repair of hernias."
Wings Mesh: "Use in all kind of hernia repair requiring reinforcement with nonabsorbable support material."
Device Description
Monofilament polypropylene mesh, available in various weights, rigidity, shapes and sizes, to allow an easy use in surgical techniques.
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