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510(k) K252438

Explant Express by Applied Medical Technology, Inc. — Product Code QVS

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.

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Other clearances for product code QVS

  • DEN220082 — Breast Implant Removal Device (BIRD) (April 20, 2023)