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510(k) DEN220082

Breast Implant Removal Device (BIRD) by Gaylord Solutions, LLC — Product Code QVS

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 20, 2023
Date Received
November 21, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Breast Implant Suction Retrieval Device
Device Class
Class II
Regulation Number
878.4675
Review Panel
SU
Submission Type

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.

Other clearances for product code QVS

  • K252438 — Explant Express (February 3, 2026)