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Found 15 results
510(k) Data Aggregation
K Number
K251748Device Name
MammoSTAR Biopsy Site Identifier
Manufacturer
Carbon Medical Technologies, Inc.
Date Cleared
2025-07-23
(47 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Carbon Medical Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K172227Device Name
Endoscopic Injection Needle
Manufacturer
Carbon Medical Technologies, Inc.
Date Cleared
2017-08-23
(29 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Carbon Medical Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endoscopic Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure.
Device Description
The Endoscopic Injection Needle consists of a luer lock hub, flexible cannula and retractable stainless steel needle at the distal tip. The hub is designed to accommodate a standard syringe. The device is supplied sterile and is for single patient use.
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K Number
K133148Device Name
BIOMARC COAXIAL NEEDLE
Manufacturer
CARBON MEDICAL TECHNOLOGIES, INC.
Date Cleared
2014-05-13
(208 days)
Product Code
FBK, NEU
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CARBON MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.
Device Description
The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop. The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.
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K Number
K132064Device Name
BIOMARC FIDUCIAL MARKER
Manufacturer
CARBON MEDICAL TECHNOLOGIES, INC.
Date Cleared
2014-02-28
(240 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
CARBON MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
Device Description
The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.
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K Number
K132708Device Name
BIOMARC FIDUCIAL MARKER
Manufacturer
CARBON MEDICAL TECHNOLOGIES, INC.
Date Cleared
2013-12-20
(113 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
CARBON MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biomac Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.
Device Description
The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible delivery devices chosen by the user.
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K Number
K130678Device Name
BIOMARC GOLD FIDUCIAL MARKER
Manufacturer
CARBON MEDICAL TECHNOLOGIES, INC.
Date Cleared
2013-04-12
(30 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
CARBON MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BiomarC Gold Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
Device Description
The BiomarC Gold Fiducial Marker is a sterile, pyrogen free, single patient use, gold discrete marker that is visible on standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.
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K Number
K110772Device Name
BIOMARC FIDUCIAL MARKER
Manufacturer
CARBON MEDICAL TECHNOLOGIES, INC.
Date Cleared
2011-04-28
(38 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
CARBON MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
Device Description
BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) at up to 4.0 Tesla field strength.
BiomarC Fiducial Marker is supplied pre-loaded in a sterile, pyrogen free, single patient use deployment device. The deployment device consists of a cannula with handle, a push rod with plunger, and bone wax as a marker retaining mechanism.
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K Number
K100994Device Name
PRELOADED TISSUE MARKER DEVICE
Manufacturer
CARBON MEDICAL TECHNOLOGIES, INC.
Date Cleared
2010-04-30
(21 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
CARBON MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
[Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
Device Description
[Trade Name] Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. The [Trade Name] Preloaded Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
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K Number
K070436Device Name
BIOMARC GOLD TISSUE MARKER
Manufacturer
CARBON MEDICAL TECHNOLOGIES, INC.
Date Cleared
2007-03-16
(29 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
CARBON MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
BiomarC Gold is a sterile, nonpyrogenic, single use tissue marker consisting of 99.99% metallic gold clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound BiomarC Gold is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
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K Number
K063193Device Name
MODIFICATION TO BIOMARC TISSUE MARKER
Manufacturer
CARBON MEDICAL TECHNOLOGIES, INC.
Date Cleared
2006-11-21
(32 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
CARBON MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
BiomarC is a sterile, nonpyrogenic, single use tissue marker consisting of a nonabsorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. BiomarC is provided alone or with the BiomarC Delivery Gel. BiomarC is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
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