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510(k) Data Aggregation
K Number
K073663Device Name
GELSPRAY WOUND DRESSING
Manufacturer
BIOCURE, INC.
Date Cleared
2008-01-30
(35 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
BIOCURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GelSpray™ Liquid Bandage is indicated for use to cover minor cuts, scrapes and minor irritations of the skin.
Device Description
The GelSpray™ Liquid Bandage is a two part hydrogel system, capable of rapid curing when applied to a wound bed. The GelSpray™ Liquid Bandage consists of a macromer derived from polyvinyl alcohol (PVA). When mixed, the pre-polymers utilize a redox reaction to cure, resulting in the final dressing consisting predominantly of water (approximately 80%). The pre-polymer components are initially packaged and sterilized in a two part syringe with a common plunger for delivery. A static mixer is incorporated in the delivery system to ensure a uniform and adequate mix of the two pre-polymers and to allow a controlled delivery of the dressing to its intended site. The product will be supplied sterile and packaged in a pre-filled, double barrel syringe. The target quantity will be providing the user with 4.5mL minimum.
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K Number
K023089Device Name
GELSPHERES EMBOLIC AGENT
Manufacturer
BIOCURE, INC.
Date Cleared
2002-12-16
(90 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
BIOCURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GelSpheres™ Embolic Agent is intended for embolization of hypervascular tumors and arteriovenous malformations.
Device Description
GelSpheres™ Embolic Agent are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascualr tumor or arteriovenous malformations (AVM's). GelSpheres™ Embolic Agent consists of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ Embolic Agent is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
The product is supplied sterile and packaged in sealed glass bottles for V-Series Model numbers, and in pre-filled syringes for S- Series model numbers. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ Embolic Agent in sterile physiologic buffered saline (PBS) to a volume of 8 mL. and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 8 mL. Two quantities will be available in a pre-filled syringe: (1) 1.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL, and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL.
GelSpheres™ Embolic Agent is supplied in several units covering the range from 100um to 1200um diameter.
At the time of use, GelSpheres™ Embolic Agent is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
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