QVS · Breast Implant Suction Retrieval Device
General, Plastic Surgery · 21 CFR 878.4675 · Class 2
Overview
| Product Code | QVS |
|---|---|
| Device Name | Breast Implant Suction Retrieval Device |
| Regulation | 21 CFR 878.4675 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
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. It is a single-patient, single-use device consisting of a two-piece bottle with a concave shaped nozzle and a tapered fitting port for connection to a vacuum source.
Classification Rationale
Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the risks to health.
Special Controls
In combination with the general controls of the FD&C Act, the Breast Implant Suction Retrieval System is subject to the following special controls:
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252438 | Explant Express | Applied Medical Technology, Inc. | Feb 3, 2026 | SESE |
| DEN220082 | Breast Implant Removal Device (BIRD) | Gaylord Solutions, LLC | Apr 20, 2023 | DENG |
Top Applicants
- Applied Medical Technology, Inc. — 1 clearance
- Gaylord Solutions, LLC — 1 clearance
