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Found 8 results
510(k) Data Aggregation
K Number
K014246Device Name
AVID-NIT NERVE STIMULATION NEEDLES
Manufacturer
AVID N.I.T., INC.
Date Cleared
2002-07-16
(202 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
AVID N.I.T., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug. These needles are to be used with battery powered periphera1 nerve locators only. These needles are specifically not intended for nerve stimulation for purposes other than nerve location. These needles are specifically not intended for neurolytic ablation.
Device Description
The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug.
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K Number
K013231Device Name
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
Manufacturer
AVID N.I.T., INC.
Date Cleared
2001-12-03
(67 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
AVID N.I.T., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Avid-NIT Lutz Needle is used for the percutaneous puncture of the back, over the spine and into the epidural space for the administration of anesthetic agents. This needle is not intended for use with an epidural catheter.
Device Description
Not Found
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K Number
K983218Device Name
N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
Manufacturer
AVID N.I.T., INC.
Date Cleared
1998-11-06
(53 days)
Product Code
FCG
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
AVID N.I.T., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the percutaneous punture of the abdomen or pelvis for the purpose of removing tissue of the soft tissue organs for microscopic examination, for the purpose of diagnosis of disease. The needle is to be used with the automatic biopsy devices marketed by C.R. Bard and Manan Medical Products.
Device Description
Automatic Cutting Needle
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K Number
K972595Device Name
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
Manufacturer
AVID N.I.T., INC.
Date Cleared
1998-05-20
(313 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
AVID N.I.T., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aldrete Single Shot Epidural Needle is intended to be used for the injection of local anesthetics to provide regional anesthesia.
Device Description
Not Found
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K Number
K972554Device Name
REGANES RADIONUCLIDE SEED MAGAZINE
Manufacturer
AVID N.I.T., INC.
Date Cleared
1998-02-17
(224 days)
Product Code
IWJ
Regulation Number
892.5650Why did this record match?
Applicant Name (Manufacturer) :
AVID N.I.T., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator. This device performs the same function as the reusable magazines sold by Mick Radionuclear Instruments, Inc.
Device Description
A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator.
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K Number
K973037Device Name
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
Manufacturer
AVID N.I.T., INC.
Date Cleared
1998-01-27
(166 days)
Product Code
IWJ
Regulation Number
892.5650Why did this record match?
Applicant Name (Manufacturer) :
AVID N.I.T., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.
Device Description
The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy.
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K Number
K973638Device Name
N.I.T., INC. NEEDLE GUIDING TEMPLATE
Manufacturer
AVID N.I.T., INC.
Date Cleared
1997-12-23
(90 days)
Product Code
IWJ
Regulation Number
892.5650Why did this record match?
Applicant Name (Manufacturer) :
AVID N.I.T., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid for the placement of radionuclide seeds into the body. Coordinate system assure to place the template in proximity to, but not touching the perineum for seed placement into and around the prostate.
Device Description
The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid
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K Number
K971645Device Name
REGANES SPINAL NEEDLE (VARIOUS)
Manufacturer
AVID N.I.T., INC.
Date Cleared
1997-08-01
(88 days)
Product Code
MIA
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
AVID N.I.T., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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