QVS — Breast Implant Suction Retrieval Device Class II
FDA product code QVS covers "Breast Implant Suction Retrieval Device", a Class II medical device regulated under 21 CFR 878.4675. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QVS
- Device Class
- Class II
- Regulation Number
- 878.4675
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.