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510(k) Data Aggregation
K Number
K213053Device Name
Gold Anchor
Manufacturer
Naslund Medical AB
Date Cleared
2022-01-06
(106 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Naslund Medical AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Device Description
The Gold Anchor™ marker is a fiducial gold marker intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. The marker is formed as a wire with cutouts and used to locate and delineate a tumor, lesion, or other site of interest.
The Gold Anchor™ Introducer ("Introducer") is delivered pre-loaded with the Gold Anchor™ marker inside. It comes in a blister single pack, sterilized, ready for use. The Introducer is used to transfer the marker over into a 22 gauge endoscopic ultrasound aspiration needle ("22G EUS Needle").
Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.
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K Number
K201117Device Name
Gold Anchor
Manufacturer
Naslund Medical AB
Date Cleared
2020-06-11
(45 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Naslund Medical AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Device Description
The Gold Anchor™ Marker is a fiducial gold marker intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. The marker is formed as a wire with cutouts and used to locate and delineate a tumor, lesion, or other site of interest. The marker comes pre-loaded in 25G, 22G and 20G needles delivered sterile and ready for use. Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.
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K Number
K160209Device Name
Gold Anchor
Manufacturer
NASLUND MEDICAL AB
Date Cleared
2016-06-21
(145 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NASLUND MEDICAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Device Description
The Gold Anchor™ Marker is a fiducial gold marker intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. The marker is formed as a wire with cutouts and used to locate and delineate a tumor, lesion, or other site of interest. The marker comes pre-loaded in 25G, 22G and 20G needles delivered sterile and ready for use. Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.
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K Number
K091645Device Name
GOLD ANCHOR
Manufacturer
NASLUND MEDICAL AB
Date Cleared
2009-07-21
(47 days)
Product Code
IYE, IVE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NASLUND MEDICAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gold Anchor is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Device Description
The Gold Anchor Marker consists of a thin gold wire with cutouts delivered in a fine needle. The Gold Anchor Marker is available pre-loaded in two different sizes of fine needles: Gold Anchor 120 comes in a 0.53 mm x 120 mm (25 G x 4 3/4") fine needle with an attached injector, and Gold Anchor 200 comes in a 0.7mm x 203mm (22G x 8") fine needle. The Gold Anchor comes in blister single packs, sterilized, ready for use, in lengths of 1-5cm, clearly indicated on the package. They shall be implanted under guidance of ultrasound or CT or during manual palpation of the tumor. The Gold Anchor Marker can be inserted in the tissue in two ways, either through advancing the stylet or by withdrawing the needle. If the stylet is advanced rather than the needle withdrawn, the Gold Anchor Marker will collapse and fold into different shapes. By withdrawing the needle the Gold Anchor Marker will be deposited as a straight line in the needle track.
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