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510(k) Data Aggregation
K Number
K210675Device Name
EasyWhip
Manufacturer
Date Cleared
2021-05-03
(59 days)
Product Code
Regulation Number
878.5000Why 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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