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U.S. Department of Health and Human Services

Product Classification

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Device vacuum syringe
Regulation Description Piston syringe.
Definition The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid.
Physical State The vacuum syringe consists of a barrel, plunger, piston seal and a locking mechanism.
Technical Method A vacuum syringe may be used in instances where fluid and/or tissue needs to be removed from the body in the form of thrombus, abscess fluid, and infected fluid (e.g. urine, bile, etc,). Thrombus and other fluid can be thick, which makes it difficult to aspirate. The locking feature of the Vacuum Syringe allows the user to aspirate by pulling the plunger back to the desired position and locking the plunger, creating a continuous vacuum, which can be used to aspirate the fluid or thrombus without the need to continuously hold the plunger back.
Target Area Human fluid
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePUR
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible