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510(k) Data Aggregation
K Number
K051073Device Name
MIDIVIEW SERIES OF MICROENDOSCOPES
Manufacturer
MILLENNIUM DEVICES, INC.
Date Cleared
2006-05-17
(386 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MILLENNIUM DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Millennium Devices Inc. Midiview Series of MicroEndoscopes are intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures. The Sialoview series of microendoscopes are for use by qualified surgeons for the diagnosis and treatment of salivary gland diseases. The Sialoview scopes are used to visualize the surgical site in salivary gland diagnosis and therapeutic procedures.
Device Description
The Millennium Devices Inc. MDI-View MicroFibre Endoscope Series and Accessories are fiber optic based flexible and semi rigid endoscopes intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals. They also provide working channels to allow insertion of tools and accessories such as drills and stone baskets to facilitate therapeutic procedures. All scopes incorporate an irrigation channel that may provide irrigant flow to the distal end for flushing the operative site. All of the endoscopes are semi rigid, except the SinoView scopes which are flexible. All incorporate a 0.35 mm diameter, 6000 pixel fiber bundle. The SinoView scope is flexible. Surrounding this bundle are fibre cables that are used as light guides. Standard glass lens oculars are provided. Stainless steel sheaths are used for the endoscopes. Fach scope may be attached to standard Fibre Optic light sources and cameras such as the Olympus CLV-160 light source and the Karl Storz Xenon 300 light source. They may also be connected to CCD video adapters that in turn may be used to project the image on standard medical grade TV monitors. All models also include working channels that may be used to introduce accessories such as biopsy needles, stone baskets, drills or other standard type tools. These tools allow the endoscopes to be used in therapy as well as diagnosis of disease.
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