Product code QVS

Device name

Breast Implant Suction Retrieval Device

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4675

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset