# DEN220082: Breast Implant Removal Device (BIRD)

- Pathway: De Novo (Direct)
- Applicant: Gaylord Solutions, LLC
- Decided: Apr 20, 2023 after 150 days
- Product code: QVS (Breast Implant Suction Retrieval Device)
- Device class: 2
- Regulation: 21 CFR 878.4675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K252438: Explant Express (2026), 0 descendants of its own

## Indications for use
The Bateman™ Bottle is a single-patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant. Not intended for en bloc removal. Not intended to remove residual silicone or be applied directly to tissue.

Source page: https://510kreport.com/device/DEN220082
Methodology: https://510kreport.com/methodology