DEN220082 is an FDA 510(k) submission for the Breast Implant Removal Device (BIRD). This device is classified as a Breast Implant Suction Retrieval Device (Class II - Special Controls, product code QVS).
Submitted by Gaylord Solutions, LLC (Gaylord, US). The FDA issued a Not Cleared (DENG) decision on April 20, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4675. 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..
| 510(k) Number | DEN220082 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 21, 2022 |
| Decision Date | April 20, 2023 |
| Days to Decision | 150 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | QVS - Breast Implant Suction Retrieval Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4675 |
| 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. |