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510(k) Data Aggregation

    K Number
    K210675
    Device Name
    EasyWhip
    Date Cleared
    2021-05-03

    (59 days)

    Product Code
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Winter Innovations, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Easy Whip™ is indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopedic surgeries.
    Device Description
    EasyWhip™ is a non-absorbable suture with specialized needle that simplifies and standardizes existing manual suturing methods as a convenience to surgeons. It is designed to facilitate easy, fast, and accurate stitch placement with less variation. EasyWhip™ is versatile and enables several stitch techniques or patterns, including a whip stitch, a WhipLock™ stitch (which combines a whip stitch with a locking stitch similar to a Krakow stitch), and custom patterns according to individual user needs and preferences. EasyWhip™ consists of a single USP size 2, braided 40" strand of suture (20" loop) with portions of a two-part needle attached to each end. The needle portions consist of a tip with a sharp point and a dull insert that slides within the needle tip during stitching. The suture is non-absorbable Ultra-High Molecular Weight Polyethylene (UHMWPE) dyed black (D&C Black #4 not to exceed 1.0% by weight). The device is provided sterile for single use only. EasyWhip™ meets all surgical suture requirements established by USP for non-absorbable surgical sutures, except for oversize diameter.
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