K252438 is an FDA 510(k) clearance for the Explant Express. This device is classified as a Breast Implant Suction Retrieval Device (Class II - Special Controls, product code QVS).
Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on February 3, 2026, 186 days after receiving the submission on August 1, 2025.
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 | K252438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2025 |
| Decision Date | February 03, 2026 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |