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QVS

Breast Implant Suction Retrieval Device

Product code
QVS
Device name
Breast Implant Suction Retrieval Device
Device class
Class 2
21 CFR
21 CFR 878.4675
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-02-03.

NumberDecision dateApplicantDevice nameSummary
K2524382026-02-03Applied Medical Technology, Inc.Explant ExpressPDF

1 summaries are archived here for direct download.

Official FDA classification page: QVS
Classification and pathway per current FDA publications. Data from openFDA (CC0).