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510(k) Data Aggregation
K Number
K191011Device Name
Scope ProTech
Manufacturer
Meditech Endoscopy Ltd
Date Cleared
2019-05-07
(21 days)
Product Code
OCU
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Meditech Endoscopy Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. The Scope ProTech is intended for the protection of the distal tip and the bending rubber of endoscopes with a diameter of 2.7mm-8.0mm and 8.7mm-14.7mm. The Scope ProTech will aid in the protection of distal end, the lens and other delicate components from damage. It is not intended for use during sterilization.
Device Description
The Scope ProTech is a single-use, sterile endoscopic tip protector which provides a simple, safe, and highly effective method of protecting the delicate optics of an endoscope, while allowing the tip to 'breath' and thus not allowing biofilm to form. The Scope ProTech is available in two models to fit a range of scopes: INOV8-028S (Scope ProTech Small) for scope sizes 2.7 to 8mm and INOV8-028L (Scope ProTech Large) for scope sizes 8.7 to 14.7mm. The Scope ProTech is manufactured using injection moulding using a soft polypropylene.
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