Explant Express
FDA 510(k) clearance K252438 · decided 2026-02-03
Clearance details
- K-number
- K252438
- Device name
- Explant Express
- Applicant
- Applied Medical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-01
- Decision date
- 2026-02-03
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- QVS
- Device class
- 2
- Regulation number
- 878.4675
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Brecksville, OH, 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 |
|---|---|---|
| Breast Implant Removal Device (BIRD) (DEN220082) | Gaylord Solutions, LLC | 2023-04-20 |
Recalls involving this device
No recalls on record reference this clearance.