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510(k) Data Aggregation
K Number
K012614Device Name
KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN
Manufacturer
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
Date Cleared
2002-05-01
(261 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of a compression sleeve is to aid in blood circulation in bed confined patients, to prevent deep vein thrombosis and pulmonary embolism.
The intended use of a compression sleeve is to increase venous blood flow in bed-confined patients, to prevent deep vein thrombosis and pulmonary embolism.
Device Description
Compression sleeves come in 3 adjustable sizes for the leg, one size for the knee and various sizes for the foot. They are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to squeeze the blood out of the foot or leg and deflates to allow the blood to flow back into the foot or leg. On many of the machines, air pressure can be adjusted to allow for the length and thickness of the leg.
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K Number
K012640Device Name
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
Manufacturer
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
Date Cleared
2002-02-28
(199 days)
Product Code
HRX, GEI
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders.
Device Description
The cutting and coagulation system consists of a system controller that is connected to a power source. Two cables extend from the system controller, one to a foot-pedal to allow the operator to control the device; the other cable leads to the wand portion, which functions in the surgical site. The wand is the accessory for which MIT has developed the reprocessing technology.
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K Number
K012624Device Name
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS
Manufacturer
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
Date Cleared
2001-11-08
(87 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Arthroscopy Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Simus Surgery (FESS). The FESS application is limited to those small blades, which are appropriate for the procedure.
Device Description
The arthroscopic blade is composed of stainless steel tubing with plastic connectors. A small tube is fitted within a larger tube. The distal ends of the tubes are serrated and/or sharpened. The proximal end of each stainless steel tube is insertion molded into plastic connectors. The inner tube is fitted into the outer tube. The inner tube rotates within the outer tube and creates a scissor action that cuts soft tissue in the arthroscopy procedure. The assembled arthroscopic blade is connected to a power device that is adjusted by the clinician to rotate the inner tubing during use at the selected RPMs. Depending on the size and configuration of the device, the inner tube may be fitted with a plastic sheathing, or copper bearings, may be plated with an alloy such as nickel/tin and may be lubricated to facilitate rotation within the outer shaft. In addition the inner and outer tubes must be straight with no bends or kinks to ensure adequate rotation of the shafts during use. Burs must be absent from the cutting edges to prevent inadequate rotation and freezing up of the inner shaft during use.
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K Number
K012632Device Name
TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
Manufacturer
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
Date Cleared
2001-10-26
(74 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of a tourniquet cuff is to restrict blood flow to a patient's limb during surgery.
Device Description
Tourniquet cuffs are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to restrict the blood flow in the limb during surgery.
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