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510(k) Data Aggregation

    K Number
    K222944
    Device Name
    SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
    Manufacturer
    SafePath Medical, Inc.
    Date Cleared
    2024-10-18

    (753 days)

    Product Code
    GAP, GAR, GAW
    Regulation Number
    878.5030
    Why did this record match?
    Applicant Name (Manufacturer) :

    SafePath Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SafePath Suturing System - Silk Suture: The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues. SafePath Suturing System - Polyamide (Nylon) Suture: The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues. SafePath Suturing System - Polypropylene Suture: The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.
    Device Description
    The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch. The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch. The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch. Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.
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    K Number
    K180701
    Device Name
    SafePath Suturing System
    Manufacturer
    SafePath Medical, Inc.
    Date Cleared
    2018-06-25

    (101 days)

    Product Code
    GAP, GAB
    Regulation Number
    878.5030
    Why did this record match?
    Applicant Name (Manufacturer) :

    SafePath Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
    Device Description
    The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 30 in. length, swaged on a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch. Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue. The System Includes: (2) Suturing Device Pre-loaded with one (1) 30 in. strand of USP size 2-0 black braided silk suture Swaged on a ½ circle, 26 mm reverse cutting needle
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