510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QVSClass II

Breast Implant Suction Retrieval Device

21 CFR 878.4675 / General, Plastic Surgery
FDA source (opens on fda.gov)

QVS is the FDA product code for Breast Implant Suction Retrieval Device, a class II device type, regulated under 21 CFR 878.4675. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QVS
Device name
Breast Implant Suction Retrieval Device
FDA 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.
Regulation
21 CFR 878.4675
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QVS

By decision year
2 clearances under product code QVS with a decision year between 2023 and 2026, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QVS by decision year
YearClearances
20231
20261

Applicants with the most clearances

Product code QVS
Applicants holding the most 510(k) clearances under product code QVS
ApplicantClearances
Applied Medical Technology Inc1
Gaylord Solutions, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code