QVS · Class II · 21 CFR 878.4675

FDA Product Code QVS: Breast Implant Suction Retrieval Device

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.

Leading manufacturers include Applied Medical Technology, Inc..

2
Total
1
Cleared
168d
Avg days
2023
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 186d recently vs 150d historically

FDA 510(k) Cleared Breast Implant Suction Retrieval Device Devices (Product Code QVS)

2 devices
1–2 of 2
Cleared Feb 03, 2026
Explant Express
K252438
Applied Medical Technology, Inc.
General & Plastic Surgery · 186d

About Product Code QVS - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QVS since 2023, with 1 receiving FDA clearance (average review time: 168 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under QVS have taken an average of 186 days to reach a decision - up from 150 days historically. Manufacturers should account for longer review timelines in current project planning.

QVS devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →