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510(k) Data Aggregation
(176 days)
KSEA ARTHROPUMP PLUS
The Karl Storz Arthropump Plus system is designed to provide irrigation and aspiration of the surgical site during arthroscopic surgical procedures.
These instruments are intended for use by qualified surgeons and provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures.
The Karl Storz Arthropump Plus and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction underpressure.
This 510(k) summary for the Karl Storz Arthropump Plus system states that it is substantially equivalent to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a regulatory approval and not a detailed performance study.
Therefore, I cannot provide the requested information based on the input text. The input does not describe a study or acceptance criteria for device performance.
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