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510(k) Data Aggregation
K Number
K052067Device Name
DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
Manufacturer
MULTIGON INDUSTRIES, INC.
Date Cleared
2005-08-29
(28 days)
Product Code
JAF
Regulation Number
892.1540Why did this record match?
Applicant Name (Manufacturer) :
MULTIGON INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 500H Doppler Guided Proctoscope is used to detect blood vessels supplying hemorrhoids and for performing HAL ( Hemorrhoid Arterial Ligation) for Class II and Class III hemorrhoids. It is to be used by physicians in hospitals, clinics, and physician's offices by prescriptions or doctor's orders.
Device Description
The model 500H Doppler guided proctoscope consists of two parts . The first part is a Doppler probe in a proctoscope that are used integrally with each other and are not intended to be used separately. The Doppler guided proctoscope has a removable fiber optic light pipe, and a removable 8 mHz CW Doppler probe. The second part is a combination 8 mHz continuous wave (CW) Doppler detector with loudspeaker and a light source. The Doppler guided proctoscope is inserted in the rectum and rotated until one of the branches of the hemorrhoidal artery is located. The artery is located when the user hears the classical arterial blood flow sound. The Doppler guided proctoscope is rotated such that the arterial sound is maximized thus insuring that the hemorrhoidal artery is under the Doppler probe and in the Doppler guided proctoscope's rectangular slit. The physcician or surgeon can then ligate the artery . The Doppler guided proctoscope is then rotated until the next hemorrhoidal artery branch is detected. The process is repeated until all detected hemorrhoidal arteries are located and ligated. After ligation the Doppler guided proctoscope can be rotated 360 degrees to make sure that all of the hemorrhoidal arterial branches have been ligated.
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K Number
K051739Device Name
POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB.
Manufacturer
MULTIGON INDUSTRIES, INC.
Date Cleared
2005-07-28
(30 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
MULTIGON INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 500P Transcranial and Vascular Doppler is to be used for the assessment of circulation in the adult cephalic, (intracranial and extracranial) and peripheral vascular vessels. It is to be used in hospitals, clinics and physicians offices by trained medical personnel by prescriptions or doctors orders. It is not to be used for Obstetrics.
Device Description
The 500P device consists of a battery operated (also can be used with a medical grade AC adapter) Doppler and display unit with a choice of 2 mHz, 4 mHz, 5 mHz or 8 mHz transducers. The 2 mHz probe is a pulsed Doppler, used for insonating the adult intracranial arteries. The 4mHz, 5 mHz or 8 mHz CW probes are used for insonating the peripheral arteries. The system consists of the transducers, system electronics, a memory and a USB interface for an external computer. All of the transducers are connected to the system using quick disconnect connectors. The 500P Transcranial and Vascular Doppler provides the healthcare professional with the state of blood flow in the intracranial and extracranial vascular arteries.
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