510(k) K252438
- Device
- Explant Express
- Applicant
- Applied Medical Technology, Inc.
- 510(k) number
- K252438
- Product code
- QVS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-03
- Date received
- 2025-08-01
- Regulation
- 878.4675
- Classification name
- Breast Implant Suction Retrieval Device
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Steven Curtis
- Address
- 8006 Katherine Blvd. Brecksville OH US 44141 44141
FDA Registration Numbers#
- 1526012
Source Documents#
Other 510(k) Records For Product Code QVS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220082 | Breast Implant Removal Device (BIRD) | Gaylord Solutions, LLC | 2023-04-20 |