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510(k) Data Aggregation
K Number
K141330Device Name
ENDO-CORD
Manufacturer
ENROXTECH, INC.
Date Cleared
2014-12-15
(208 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ENROXTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to transmit light for illumination purposes from the light source to endoscopes.
Device Description
A 5mm fiber-optic light transmitting core with durable protective sleeve and stainless steel couplings at each end. One coupling is for the light source and the opposite end for connection to an endoscope. The core is inserted into a durable and reusable silicone rubber sheath. One length is available: 7.5 Feet. Field replaceable fiber-optic core.
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