Breast Implant Suction Retrieval Device
The Breast Implant Suction Retrieval Device is a prescription surgical device that uses vacuum suction to assist surgeons in the removal and containment of ruptured silicone breast implants, minimizing tissue contact with silicone gel and facilitating complete extraction of fragmented implant material during explantation procedures. Classified as FDA Class 2 under regulation 878.4675, it requires 510(k) clearance in the General and Plastic Surgery specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QVS
- Device Class
- FDA class 2
- Regulation Number
- 878.4675
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.