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510(k) Data Aggregation
K Number
K061258Device Name
TRABECTOME HIGH FREQUENCY GENERATOR/LP
Manufacturer
NEOMEDIX CORP.
Date Cleared
2006-05-18
(13 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEOMEDIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trabectome™ High Frequency Generator/LP is for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.
Device Description
The Trabectome™ High Frequency Generator/LP is a non-sterile, reusable electrosurgical generator. The device is designed to generate high frequency (radiofrequency "RF") high voltage and low amperage current. The device operates in either the monopolar or the bipolar mode. The device is available in two voltage models: 110 VAC or 220 VAC (for international use). The generator is activated through an input jack on the front panel. The activation can be via a footswitch or other single pole closure device with a compatible plug.
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K Number
K040584Device Name
NMX-1000
Manufacturer
NEOMEDIX CORP.
Date Cleared
2004-04-22
(48 days)
Product Code
GEI, HQR
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEOMEDIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NMX-1000™ is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.
Device Description
The NMX-1000™ is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical tubing designed to operate in the bipolar model. The handpiece is ABS plastic and incorporates a stainless steel probe of low energy output control. The special production of the device model is supplied when connected to a compatible electrosurgical generator of the handpiece to standard irrigation and aspiration devices.
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K Number
K040239Device Name
SUPRAFLOW CONSOLE
Manufacturer
NEOMEDIX CORP.
Date Cleared
2004-02-17
(15 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
NEOMEDIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoMedix SupraFlow Console is an aspiration pump intended for use in general surgery applications where aspiration of irrigation and waste fluid from a surgical site is desired. The device is not indicated for liposuction use.
Device Description
The Console contains a roller pump to provide aspiration from the surgical site and a pinch valve to initiate the flow of irrigation fluid simultaneously with the optional foot switch con switch con be used to activate both actions.
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K Number
K024304Device Name
MICROSURGICAL BIPOLAR HANDPIECE
Manufacturer
NEOMEDIX CORP.
Date Cleared
2003-02-25
(63 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
NEOMEDIX CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe for the purpose of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.
Device Description
The Handpiece is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical grade tubing with standard luer fittings. The Handpiece is ABS plastic and incorporates a stainless steel probe designed to operate in the bipolar mode when connected to any compatible bipolar electrosurgical generator capable of low energy output control. The irrigation and aspiration sets provide for connection of the handpiece to irrigation and aspiration devices.
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