Breast Implant Suction Retrieval Device

QVS · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4675

Classification

FDA Product Code: QVS
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4675
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown