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510(k) Data Aggregation
K Number
K993738Device Name
DISPOS-A-SCOPE
Manufacturer
DISPOS-A-SCOPE
Date Cleared
2000-01-06
(63 days)
Product Code
FER
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
DISPOS-A-SCOPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy.
Device Description
The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy. The Dispos-A-Scope has 11cm speculum length enabling visualization of the ano-rectal canal. The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument. The Dispos-A-Scope is non-powered. It does not conduct electricity and is non-thermogenic. The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack or craze during normal usage. The Dispos-A-Scope has an operative port enabling precise isolation of tissue and pathology. The Dispos-A-Scope has a replaceable obturator facilitating device insertion and rotation for precise operative port placement during examination and treatment procedures. The Dispos-A-Scope has an ergonomic handle facilitating accurate physician manipulation.
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