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 Gaylord Solutions, LLC and 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
Cleared
Feb 03, 2026
Explant Express
Applied Medical Technology, Inc.
General & Plastic Surgery
186d
Not Cleared
Apr 20, 2023
Breast Implant Removal Device (BIRD)
Gaylord Solutions, LLC
General & Plastic Surgery
150d
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 510(k) Review Time - QVS Product Code
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 →