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510(k) Data Aggregation
K Number
K962330Device Name
AMO ARTHOSCOPES
Manufacturer
AMERICAN MICROPTIKS, INC.
Date Cleared
1996-09-11
(86 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN MICROPTIKS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Like other legally marketed arthroscopes, the AMO Arthroscope is indicated for use in minimally invasive procedures of the knee, shoulder and ankle joints, for joint examination, biopsy, arthroscopy, diagnosis of ioint disease.
The device provides a clear view of the joint structures such as femoral condyles, medial meniscus, cruciate ligament, and other anatomical structures.
Device Description
The AMO Arthroscope is a device that will be provided non-sterile for arthroscopic procedures. The device has a basic design similar to those already sold legally in the U.S.A. Its construction consists of an eyepiece, body, light guide and a shaft. The shaft contains an outer tube, an inner tube, with light-carrying fibers sandwiched between these tubes. The inner tube contains the optical system.
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