QVS
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Breast Implant Suction Retrieval Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4675
- Medical specialty
- General, Plastic Surgery
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Explant Express (K252438) | Applied Medical Technology, Inc. | 2026-02-03 |
| Breast Implant Removal Device (BIRD) (DEN220082) | Gaylord Solutions, LLC | 2023-04-20 |
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