BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Explant Express

    K Number: K252438 · Decision Feb 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    25
    Review Days
    186

    Basic Information

    Device Name
    Explant Express
    K Number
    K252438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4675
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Technology, Inc.
    Date Received
    August 1, 2025
    Decision Date
    February 3, 2026
    Product Code
    QVS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QVS Breast Implant Suction Retrieval Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QVS), ordered by most recent decision date.

    Breast Implant Removal Device (BIRD)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Applied Medical Technology, Inc.

    K Number Device Name
    K240514 AMT Low-Profile Suprapubic Catheter & Drainage Set
    K241111 AMT Suture Passer
    K222846 AMT G-Tube Balloon Gastrostomy Feeding Device
    K202539 Nutriglide(TM) Nasal Feeding Tube
    K193612 AMT Suture Delivery System
    K183508 Micro Transgastric-Jejunal Feeding Device
    K182804 Traditional Length GJ Feeding Device
    K180026 Bowel Management Device, Bowel Management Irrigation Set
    K170319 Low Profile Non-Balloon Feeding Device
    K161413 Low Profile Balloon Feeding Device
    Search all 25 clearances from Applied Medical Technology, Inc. →