Explant Express— 510(k) K252438
Substantially EquivalentApplied Medical Technology, Inc.
FDA 510(k) clearance K252438 for Explant Express, Substantially Equivalent on 2026-02-03. Applicant: Applied Medical Technology, Inc.. Device class: 2.
Summary
Applied Medical Technology's Explant Express is filed under product code QVS, breast implant suction retrieval device. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 878.4675. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Applied Medical Technology filed from Brecksville, Ohio. FDA found it substantially equivalent 186 calendar days after receipt (August 1, 2025 to February 3, 2026).
Clearance details
- Applicant
- Applied Medical Technology, Inc.
- Product code
- Product code QVS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4675
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brecksville, OH, US
Recent devices under product code QVS
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