Breast Implant Removal Device (BIRD)
FDA 510(k) clearance DEN220082 · decided 2023-04-20
Clearance details
- K-number
- DEN220082
- Device name
- Breast Implant Removal Device (BIRD)
- Applicant
- Gaylord Solutions, LLC
- Decision
- Unknown
- Date received
- 2022-11-21
- Decision date
- 2023-04-20
- Days to decision
- 150 days
- Clearance type
- Direct
- Product code
- QVS
- Device class
- 2
- Regulation number
- 878.4675
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gaylord, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Explant Express (K252438) | Applied Medical Technology, Inc. | 2026-02-03 |
Recalls involving this device
No recalls on record reference this clearance.