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510(k) Data Aggregation
K Number
K020702Device Name
O'REGAN DISPOSABLE ANOSCOPE
Manufacturer
CANADIAN THEATRE PRODUCTS LTD.
Date Cleared
2002-03-29
(25 days)
Product Code
FER
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CANADIAN THEATRE PRODUCTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The O'Regan Disposable Anoscope is intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description
Similar to device's marketed prior to or after May 28, 1976. The O'Regan Disposable Anoscope is identical to other legal marketed devices such as the Dispos-A-Scope in terms of material, disposability, non-powered, design, and usage. The O'Regan Disposable Anoscope is constructed from a Medical Grade-Atohass Medical SG& 101PH material, and is FDA certified. The O'Regan Disposable Anoscope is for single patient use only, thus disposable eliminating the risk of cross infection and nullifying the need for sterilization. The O'Regan Disposable Anoscope is non-powered. It does not conduct electricity and is nonthermogenic. The O'Regan Disposable Anoscope has a distal and proximal port enabling precise isolation and accuracy of tissue or pathology. The O'Regan Disposable Anoscope has an ergonomic handle facilitating accurate physician manipulation. The O'Regan Disposable Anoscope will not crack or craze during normal one time usage.
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