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510(k) Data Aggregation

    K Number
    K200392
    Device Name
    REXSIN
    Manufacturer
    SM ENG CO., LTD
    Date Cleared
    2020-07-07

    (140 days)

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

    SM ENG CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
    Device Description
    Synthetic Absorbable PGA Suture With or Without Needle (REXSIN) are produced and provided by SM ENG Co., Ltd. REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. Suture of REXSIN is Trisorb manufactured by SAMY ANG Biopharmaceuticals Corporation. SM Eng is receiving bulk Trisorb from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes REXSIN suture. REXSIN is a sterilized medical device composed with absorbable, braided, coated suture with needle, stainless steel SUS 304. REXSIN Suture is a synthetic absorbable, braided, coated suture composed of a Polyglycolic acid (PGA). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately over 65% of tensile strength remain after 2week. Complete absorption in tissues takes around 90 days. REXSIN Sutures meets requirements established by the United States Pharmacopoeia (USP) for Absorbable Surgical Sutures. REXSIN Sutures is available in 8-0, 7-0, 6-0, 5-0, 2-0, 0, 1 and 2, which are the sizes identified in the currently recognized United States.
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    K Number
    K173747
    Device Name
    REXLENE
    Manufacturer
    SM ENG CO., LTD
    Date Cleared
    2018-12-21

    (378 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SM ENG CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REXLENE is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
    Device Description
    REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304. REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue. REXLENE suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below. - Dyed suture blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1
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    K Number
    K173779
    Device Name
    REXMONO, PDREX
    Manufacturer
    SM ENG CO., LTD
    Date Cleared
    2018-03-12

    (90 days)

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

    SM ENG CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REXMONO is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.
    Device Description
    REXMONO: Synthetic Absorbable PGA-PCL Monofilament Suture With or Without Needle (REXMONO) are produced and provided by SM ENG Co., Ltd. REXMONO is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. Suture of REXMONO manufactured by SAMYANG Biopharmaceuticals Corporation, which is called MONOFAST. SM Eng is receiving bulk MONOFAST from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes REXMONO suture. REXMONO is a sterilized medical device composed with absorbable monofilament suture, poly (glycolide-co-caprolactone), with needle, stainless steel SUS 304. REXMONO Suture is a synthetic absorbable, monofilament, suture composed of poly (qlycolide-co-caprolactone). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 68~78% of tensile strength remain after 1 week. Complete absorption in tissues takes around 90 to 110 days. PDREX: Synthetic Absorbable Monofilament Polydioxanone Suture With or Without Needle (PDREX) are produced and provided by SM ENG Co., Ltd. PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue. Suture of PDREX manufactured by SAMYANG Biopharmaceuticals Corporation, which is called MONOSORB. SM Eng is receiving bulk MONOSORB from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes PDREX suture. PDREX is a sterilized medical device composed with polydioxanone surgical suture, with needle, stainless steel SUS 304. PDREX Suture is a synthetic absorbable, monofilament, suture composed of a Poly (p-dioxanone). The suture is available dyed (D&C Violet No.2). Approximately 50~60% of tensile strength remain after 6 week. Complete absorption in tissues takes around 180 to 210 days.
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    K Number
    K161633
    Device Name
    REXLON, REXSIL
    Manufacturer
    SM ENG CO., LTD
    Date Cleared
    2017-03-02

    (262 days)

    Product Code
    GAR, GAP
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SM ENG CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
    Device Description
    REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304. REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural). REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304. REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural). REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.
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    K Number
    K161629
    Device Name
    CRYLREX
    Manufacturer
    SM ENG CO., LTD
    Date Cleared
    2017-02-10

    (242 days)

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

    SM ENG CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CRYLREX® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
    Device Description
    CRYLREX® is a sterilized medical device composed with multifilament absorbable, braided, coated suture, 90% glycolide and 10% L-lactide, with needle, stainless steel SUS 304. CRYLREX® Suture is a synthetic absorbable, braided, coated suture composed of a copolymer made from 90% glycolide and 10% L-lactide and is available both dyed and undyed. CRYLREX® Suture is coated with poly(glycolideco-lactide)(30/70) and calcium stearate. The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 75% of tensile strength remain after 2 weeks, 50% of tensile strength remain after 3 weeks. Complete absorption in tissues takes around 56 to 70 days.
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