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510(k) Data Aggregation
K Number
K093409Device Name
POWERPUMP ARTHROSCOPY SYSTEM
Manufacturer
Date Cleared
2010-02-24
(114 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL VISION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PowerPump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.
Device Description
The PowerPump provides liquid irrigation and aspiration for arthroscopic procedures in one unit through two individual roller pumps. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on procedure settings chosen by the user. If needed, both flow and pressure settings can be individually adjusted. By controlling both inflow and outflow, the PowerPump accurately regulates pressure and flow in the joint. The PowerPump also provides suction when used in conjunction with a shaver. The PowerPump consists of the following articles:
1. PowerPump Unit
2. Non-sterile Foot Control
3. Non-sterile Power Cord
4. Disposable, sterile Patient Cassette
5. Disposable, sterile Day Cassette
6. Disposable, sterile PowerPump Irrigation Tubing
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