Search Results
Found 2 results
510(k) Data Aggregation
K Number
K002214Device Name
SINUSCOPE AND BACCESSORIES
Manufacturer
POLLUX ENDOSCOPY, INC.
Date Cleared
2000-11-21
(120 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
POLLUX ENDOSCOPY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K960872Device Name
CYSTOSCOPE 0/15/30/70 DEGREES
Manufacturer
POLLUX ENDOSCOPY, INC.
Date Cleared
1996-05-07
(64 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
POLLUX ENDOSCOPY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.
Device Description
This device has an overrall lenght of 354mm. This diameter of the shaft is 2.7mm for direction of the center of field of view of 0/30/70 degrees. Diameter of the shaft of 4mm for direction of the center of field of view of 0/15/30/70 dearees. This device is composed of identical materials to that of the Sight-Plus Arthroscope.
Ask a Question
Page 1 of 1