510(k) DEN220082
DEN220082 is an FDA 510(k) premarket notification submitted by Gaylord Solutions, LLC for the device "Breast Implant Removal Device (BIRD)". The FDA issued a decision of De Novo Granted on April 20, 2023. The device falls under product code QVS (Breast Implant Suction Retrieval Device), a Class II device regulated under 21 CFR 878.4675.
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.