QVS — Breast Implant Suction Retrieval Device Class II

FDA Device Classification

Classification Details

Product Code: QVS
Device Class: Class II
Regulation Number: 878.4675
Submission Type
Review Panel: SU
Medical Specialty: General, Plastic Surgery
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K252438	applied medical technology	Explant Express	February 3, 2026
DEN220082	gaylord solutions	Breast Implant Removal Device (BIRD)	April 20, 2023