BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    Steiking Packaging for Medical Devices

    K Number: K210810 · Decision Jan 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    7
    Review Days
    312

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Steiking Packaging for Medical Devices
    K Number
    K210810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wipak OY
    Date Received
    March 17, 2021
    Decision Date
    January 23, 2022
    Product Code
    FRG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRG Wrap, Sterilization

    Similar 510(k) Clearances

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

    Dukal Crepe Paper Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Pouch/Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Self-Seal Sterilization Pouch and Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Chex-All Sterilization Pouches and Tubes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Pouch and Roll

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Wipak OY

    K Number Device Name
    K232625 Steriking® Pouch for Robotic Instruments
    K231999 Steriking® LT-Blueline Pouches with Tyvek®
    K231996 Steriking® LT-Blueline Pouches with Tyvek®
    K221379 Steriking LT-Blueline Pouches with Tyvek
    K221377 SteriKing LT-Blueline Pouches with Tyvek
    K221016 Steriking Packaging for Medical Devices