FDA product code QVS: Breast Implant Suction Retrieval Device
QVS is the FDA product code for breast implant suction retrieval device. It is a Class II device, regulated under 21 CFR 878.4675 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under QVS, 1 in the last five years. The average 510(k) review took 186 days (median 186); 186 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Breast Implant Suction Retrieval Device |
| Device class | Class II |
| Regulation | 21 CFR 878.4675 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QVS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 186 |
Compare with all 510(k) review times · Search every QVS clearance
Top QVS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Medical Technology, Inc. | 1 | 2026-02-03 |
Most recent QVS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252438 | Applied Medical Technology, Inc. | Explant Express | 2026-02-03 | 186 |
Recalls for QVS devices
openFDA lists no recalls for product code QVS.
Frequently asked questions
What is FDA product code QVS?
QVS is the FDA product code for breast implant suction retrieval device. It is a Class II device, regulated under 21 CFR 878.4675 and reviewed by the General and Plastic Surgery panel.
What device class is QVS?
Class II, regulation 21 CFR 878.4675. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVS?
Across 1 cleared submissions the average was 186 days from receipt to decision (median 186).
Which companies have the most QVS clearances?
Applied Medical Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QVS
- Run a recall and safety report across every QVS manufacturer
- Watch product code QVS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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