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Found 6 results
510(k) Data Aggregation
K Number
K133453Device Name
IOVERA
Manufacturer
MYOSCIENCE INC
Date Cleared
2014-03-24
(132 days)
Product Code
GXH
Regulation Number
882.4250Why did this record match?
Applicant Name (Manufacturer) :
MYOSCIENCE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The myoscience ioveral device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the selected site for the blocking of pain. The iovera® device is not indicated for treatment of central nervous system tissue.
Device Description
The myoscience iovera® device is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip has the added functionality of having the treatment parameters being preprogrammed into its secure processor. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® device may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The device is comprised of four main components:
- A reusable Handpiece 1.
- A Charging Dock 2.
- A single-patient use Smart Tip 3.
- A Cartridge (Nitrous Oxide)
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K Number
K123516Device Name
CRYO-TOUCH IV
Manufacturer
MYOSCIENCE INC
Date Cleared
2013-01-10
(57 days)
Product Code
GXH
Regulation Number
882.4250Why did this record match?
Applicant Name (Manufacturer) :
MYOSCIENCE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Myoscience Cryo---Touch IV is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo--- Touch IV is not indicated for treatment of central nervous system tissue.
Device Description
The Myoscience Cryo-Touch IV is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N-O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The Cryo-Touch IV may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired. The device is comprised of four main components: A reusable Handpiece, A Charging Dock, A single-patient use Smart Tip, and A Cartridge (Nitrous Oxide).
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K Number
K120415Device Name
CRYO-TOUCH III
Manufacturer
MYOSCIENCE INC
Date Cleared
2012-06-22
(133 days)
Product Code
GXH
Regulation Number
882.4250Why did this record match?
Applicant Name (Manufacturer) :
MYOSCIENCE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Myoscience Cryo-Touch III is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch III is not indicated for treatment of central nervous system tissue.
Device Description
The Myoscience Cryo-Touch III is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a needle probe, "Tip" cooled by the cryogenic fluid (liguid nitrous oxide, N₂O) to a selected area. The Tip is cooled by the Joule-Thomson effect and/or Latent Heat of Vaporization. The Cryo-Touch III may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.
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K Number
K102021Device Name
CRYO-TOUCH II
Manufacturer
MYOSCIENCE INC
Date Cleared
2010-09-17
(60 days)
Product Code
GXH
Regulation Number
882.4250Why did this record match?
Applicant Name (Manufacturer) :
MYOSCIENCE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MyoScience Cryo-Touch II is used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch II is not indicated for treatment of central nervous system tissue.
Device Description
The MyoScience Cryo-Touch II is a hand-held, single patient-use disposable, cryogenic device used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The device is based on introduction of a cryoprobe cooled by the cryogenic fluid (liquid nitrous oxide) to the target nervous tissue and controlled by the user via a freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve. The Cryo-Touch II may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired. The device is comprised of three main components: a control unit (controller), probe assembly, and a cryogen cylinder assembly (Nitrous Oxide). The entire device is hand-held and for single patient-use. The Cryo-Touch II controller is battery operated; the battery powers electronics within the controller and provide feedback to the user when the device is ready to use. An assortment of needle assemblies is available for the Cryo-Touch II, ranging from a single to a triple needle, from 25 gauge to 30 gauge and 6mm in length. All needle assemblies are made of stainless steel and have a closed-tip that fully contains the cryogen so that it does not enter the target tissue. The needle assembly is the sterile patient contacting component of the Cryo-Touch II. The user removes the needle assembly from the sterile packaging and attaches it to the controller by inserting the needle hub end into the distal end of the controller. The cryogen is provided as a nitrous oxide cylinder. The cartridge is filled with liquid N₂O (83%) and the cylinder treats for approximately 180 seconds. The cylinder, once empty, may be replaced with a new cylinder by the user.
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K Number
K100447Device Name
MYOSCIENCE CRYO-TOUCH
Manufacturer
MYOSCIENCE INC
Date Cleared
2010-06-25
(128 days)
Product Code
GXH
Regulation Number
882.4250Why did this record match?
Applicant Name (Manufacturer) :
MYOSCIENCE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MyoScience Cryo-Touch is used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch is nog indicated for treatment of central nervous system tissue.
Device Description
The MyoScience Cryo-Touch is a hand-held, single patient-use disposable, cryogenic device used to destroy nervous tissue or produce lesions in peripheral nervous tissue by the application of cold to the selected site for the purposes of blocking pain. The Cryo-Touch has been developed for applications in cryoanalgesia. Cryoanalgesia for intractable pain involves the location and freezing of the nerve associated with the pain. The device is based on introduction of a cryoprobe cooled by the cryogenic fluid (liquid nitrous oxide (N₂Q)) to the selected site and activation of the freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve. The Cryo-Touch may be used with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.
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K Number
K083493Device Name
MYOSCIENCE CRYO-TOUCH
Manufacturer
MYOSCIENCE INC
Date Cleared
2009-03-20
(115 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
MYOSCIENCE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MyoScience Cryo-Touch device is intended to destroy tissue during surgical procedures by applying freezing cold.
Device Description
The MyoScience Cryo-Touch device is a hand-held, single patient-use disposable, cryosurgical instrument used for destroying tissue by subcutaneous insertion of a needle during general surgical procedures. The device is based on introduction of a needle cooled by the cryogenic fluid (liquid nitrous oxide (N₂O)) to a selected area. The needle is cooled by the Joule-Thompson effect. The Cryo-Touch comes with a variety of stainless steel closed-tip needle assemblies for use in various applications. The Cryo-Touch uses a commercially available nitrous oxide cylinder.
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