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U.S. Department of Health and Human Services

Product Classification

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Device breast implant suction retrieval device
Definition A breast implant suction retrieval system is a prescription surgical device that uses vacuum suction to assist in the removal and containment of a ruptured silicone breast implant.
Physical State A container with nozzle and port for applied suction.
Technical Method A device with a nozzle is placed within an inframammary incision to interface with the ruptured implant. Suction is applied to assist in the removal of the implant. The implant is retrieved and contained within the device.
Target Area Chest
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQVS
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4675
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