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Found 6 results
510(k) Data Aggregation
K Number
K101131Device Name
FIDUCIAL MARKERS
Manufacturer
COSMAN MEDICAL, INC.
Date Cleared
2010-06-17
(56 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
COSMAN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ball 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. Specifically, they can be used in intracranial diseases such as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas. Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.
Device Description
The Cosman Ball Fiducial Markers have similar physical and technical characteristics to the predicate devices.
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K Number
K082051Device Name
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
Manufacturer
COSMAN MEDICAL, INC.
Date Cleared
2008-10-16
(90 days)
Product Code
GXD
Regulation Number
882.4400Why did this record match?
Applicant Name (Manufacturer) :
COSMAN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cosman G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Cosman G4 Radiofrequency Generator is used with separately approved Cosman Radiofrequency Probes.
Device Description
Not Found
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K Number
K082012Device Name
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
Manufacturer
COSMAN MEDICAL, INC.
Date Cleared
2008-10-14
(91 days)
Product Code
GXI
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
COSMAN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cosman RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made.
Device Description
The Cosman RF Injection Electrodes are used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions of nerve tissue or for use in percutaneous nerve blocks.. The COSMAN CU, CUR, TCD and CCD are temperature sensing RF injection electrodes. The COSMAN CP, CR and CN are non-temperature sensing RF injection electrodes. The Cosman RF Injection Electrodes are available in a variety of lefegths and gauges. The Cosman RF Injection Electrodes are provided sterile packed and are labeled for Single Use Only.
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K Number
K060799Device Name
COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
Manufacturer
COSMAN MEDICAL, INC.
Date Cleared
2006-05-02
(39 days)
Product Code
GXI
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
COSMAN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cosman RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.
Device Description
The Cosman RF Cannula is used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions for the treatment of pain. The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The Cosman RF Cannula is provided as a sterile, single use, disposable device. The Cosman RF Cannula will be available in a variety of lengths and gauges. The Cosman RF Cannula is provided sterile packed, and is labeled for Single Use Only.
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K Number
K053415Device Name
LESIONPOINT RF CANNULA
Manufacturer
COSMAN MEDICAL, INC.
Date Cleared
2006-04-25
(139 days)
Product Code
GXI
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
COSMAN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LesionPoint RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.
Device Description
The LesionPoint RF Cannula is used in conjunction with the commercially available Cosman RFG-1A Lesion Generator (K050084) to create radiofrequency (RF) heat lesions for the treatment of pain. The LesionPoint RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The LesionPoint RF Cannula is provided as a sterile, single use, disposable device. The LesionPoint RF Cannula will be available in a variety of lengths and gauges. The LesionPoint RF Cannula is provided sterile packed, and is labeled for Single Use Only.
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K Number
K050084Device Name
COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
Manufacturer
COSMAN MEDICAL, INC.
Date Cleared
2005-03-17
(63 days)
Product Code
GXI, GXD
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
COSMAN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cosman Radiofrequency Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes, is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.
Device Description
Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes
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