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510(k) Data Aggregation
K Number
K083358Device Name
LUBRICANO-ULTRASOUND
Manufacturer
FARCO PHARMA GMBH
Date Cleared
2009-01-09
(87 days)
Product Code
MUI
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
FARCO PHARMA GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lubricano is an in vivo biocompatible and bioexcretable sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications.
Lubricano is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures, such as transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, intracavity ultrasound imaging, and gel infusion sonography.
Lubricano is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required.
Device Description
Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
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K Number
K081990Device Name
LUBRICANO STERILE GEL
Manufacturer
FARCO PHARMA GMBH
Date Cleared
2008-12-05
(144 days)
Product Code
FHX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
FARCO PHARMA GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization - particularly for incontinence treatment.
Device Description
Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano® Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano® Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
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