510(k) K252438
K252438 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "Explant Express". The FDA issued a decision of Substantially Equivalent on February 3, 2026. The device falls under product code QVS (Breast Implant Suction Retrieval Device), a Class II device regulated under 21 CFR 878.4675. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2026
- Date Received
- August 1, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Breast Implant Suction Retrieval Device
- Device Class
- Class II
- Regulation Number
- 878.4675
- Review Panel
- SU
- Submission Type
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.