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510(k) Data Aggregation
K Number
K992040Device Name
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESManufacturer
Date Cleared
1999-08-06
(50 days)
Product Code
Regulation Number
888.1100Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Schoelly Flexilux II Arthroscopes are indicated to permit a physician or surgeon to view the operative site during an arthroscopic procedure on the knee, shoulder, jaw, wrist, ankle, and elbow.
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Scholly Flexilix II Arthroscopic and Accessories". It does not contain information about the acceptance criteria, specific studies, or performance data for the device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.
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