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510(k) Data Aggregation
K Number
K080674Device Name
PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
Manufacturer
PAJUNK GMBH MEDIZINTECHNOLOGIE
Date Cleared
2008-05-09
(60 days)
Product Code
MJG
Regulation Number
878.4800Why did this record match?
Product Code :
MJG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PAJUNK®'s PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.
Device Description
With PrimoCut. PAJUNK® has developed a disposable cannula system which was especially designed for the extraction of biopsies from soft tissue tumors. Depending on the size of the biopsy material desired, there are two different dissecting lengths to choose from: 6 mm, or 15 mm. Different from the multiple-use biopsy system DeltaCut, the activating mechanism of the PrimoCut is directly integrated in the connecting hub of the cannula. This more economical alternative is disposed of completely after use. The PrimoCut is a semi-automated, spring loaded, sterile disposable device for soft tissue biopsies.
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K Number
K070836Device Name
EXICLIP EXCS-M
Manufacturer
CLEVEX INC.
Date Cleared
2007-04-20
(24 days)
Product Code
MJG, FZQ, GDO
Regulation Number
878.4800Why did this record match?
Product Code :
MJG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ExiClip™ EXCS-M is intended to provide a biopsy specimen and/or without biopsy under clinical discretion, remove skin lesions less than 6mm in diameter where simultaneous wound closure is desired.
Device Description
The ExiClip™ EXCS-M skin biopsy with wound closure device is a single use, disposable device consisting of a removable skin clip, a blade, and a manual delivery system. The device is to be provided sterile. The skin clip is non-absorbable. The skin clip provides wound closure and must be removed after the wound has healed.
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K Number
K983647Device Name
ECHO-COAT ULTRASOUND NEEDLES
Manufacturer
STS BIOPOLYMERS
Date Cleared
1999-01-20
(96 days)
Product Code
MJG
Regulation Number
878.4800Why did this record match?
Product Code :
MJG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle. The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles.
Device Description
STS Biopolymers, Inc. will purchase in bulk currently marketed needles designated by application (biopsy, aspiration, amniocentesis, etc.), needle type (spinal, Chiba, Franseen, other), needle gauge (11 to 30), and length (3 to 20 cm), and then apply a polymer coating. The coating, called ECHO-COAT™, is visible in ultrasound images, assisting with positioning. The coated needles will be repackaged as single-use devices, sterilized with EtO, and distributed commercially under the STS Biopolymers, Inc. name.
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K Number
K955683Device Name
RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
Manufacturer
CONTOUR FABRICATORS OF FLORIDA, INC.
Date Cleared
1996-02-01
(49 days)
Product Code
MJG
Regulation Number
878.4800Why did this record match?
Product Code :
MJG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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