Search Results
Found 1 results
510(k) Data Aggregation
K Number
K153701Device Name
ULYSS Multi View Sinuscope
Manufacturer
SOPRO-COMEG GMBH
Date Cleared
2016-09-09
(261 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
SOPRO-COMEG GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULYSS Multi View Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
Device Description
The ULYSS Multi View Sinuscope is a 4.3 mm rigid endoscope. The sinuscope is intended for visualization only and does not include operative channels. Instruments do not go through nor come in contact with the scope.
The handle part of the ULYSS Multi View Sinuscope incorporates two rotating dials that permit continuous adjustment of the direction of view from 10° to 100° by means of small magnets incorporated into the sinuscope body; 340° rotation of the outer tube (from -170° to +170°). The sinuscope is provided with a rod lens system to transmit images and bundled optical fibers to transmit light from an external light source to illuminate the visual field. A light guide connector is provided for connection to an Olympus®, Storz® or Wolf® light cable by means of an appropriate adapter. The endoscope is also provided with an eyepiece that is compatible with a standard camera coupler.
The ULYSS Multi View Sinuscope is a reusable device and must be cleaned and sterilized before use.
Ask a Question
Page 1 of 1