DeviceClearance

Product code QVS— General, Plastic Surgery

Breast Implant Removal Device (BIRD)

Classification name
Breast Implant Suction Retrieval Device
Device class
Class 2
Regulation
21 CFR 878.4675
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QVS under 21 CFR 878.4675, via openFDA

Market context for product code QVS

FDA has cleared 2 devices under product code QVS between 2023 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QVS

Recent clearances under product code QVS

Data sourced from openFDA. This site is unofficial and independent of the FDA.