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510(k) Data Aggregation

    K Number
    K170166
    Device Name
    CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
    Date Cleared
    2017-09-29

    (253 days)

    Product Code
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    CPT Sutures Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CARESORB® - Polyglactin 910 Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures; but not for use in cardiovascular or neurological tissues. CARESORB® RAPID - Polyglactin 910 (fast absorbing) Surgical Sutures are indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
    Device Description
    The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are multifilament, braided, sterile synthetic absorbable surgical sutures composed of a copolymer of 90% glycolide and 10% L-lactide. The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are coated with copolymer of Poly(glycolide-co-L-lactide) (30/70) and calcium stearate. The CARESORB® - Polyglactin 910 suture is available dyed with FDA-approved color additive D&C Violet No. 2 - Cl 60725 or undyed in the natural beige color. The CARESORB® RAPID - Polyglactin 910 suture is available undyed in the natural beige color only. The CARESORB® sutures are available in USP sizes 6-0 through 1 and CARESORB® RAPID sutures in USP sizes 4-0 through 2-0, in different lengths, with or without a standard needle attached. The CARESORB® and CARESORB® RAPID sutures meet USP Monograph for Synthetic Absorbable Sutures, except for diameter.
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