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): 2

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.

Number	Decision date	Applicant	Device name	Summary
K252438	2026-02-03	Applied Medical Technology, Inc.	Explant Express	PDF

1 summaries are archived here for direct download.

Official FDA classification page: QVS

Classification and pathway per current FDA publications. Data from openFDA (CC0).