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U.S. Department of Health and Human Services

Product Classification

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Device wound drain catheter system
Regulation Description Powered suction pump.
Definition For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
Physical State The system comprise of a silicone drainge tube, guide tube with integrated magnetic shuttle assembly.
Technical Method The system employs a magnetic clearance mechanism integrated into the drainage tubing to allow the user to clear materials which may accumulate inside the drainage tube.
Target Area For use in chest areas following thoracic surgical procedures.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOTK
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 878.4780
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible