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510(k) Data Aggregation

    K Number
    K141007
    Device Name
    DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2014-09-25

    (160 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "DemeSTEEL" is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.
    Device Description
    Demetech's DemeSTEEL is a Monofilament and/or Multifilament Non-absorbable surgical suture composed of 316L Stainless Steel and supplied with and without needles affixed to the sutures. Demetech's DemeSTEEL Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. DemeSTEEL Stainless Steel sutures are composed of 316L stainless steel conforming to the FDA recognized ASTM Standard F138 Grade 2 "Stainless steel bar and wire for surgical implants".
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    K Number
    K123940
    Device Name
    DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2014-05-30

    (526 days)

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

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in general soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.
    Device Description
    DemeQUICK Absorbable suture is an absorbable sterile surgical suture composed of copolymers made from 90% alvcolide and 10% L-lactide. DemeQUICK Absorbable suture is coated with a copolymer made from 30% glycolide 70% L-lactide and calcium stearate, it is available un-dved from sizes: USP 6-0 to USP 2. The DemeQUICK Absorbable suture complies with the requirements established by the United States Pharmacopoeia (USP) for absorbable suture, with tensile strength meeting the collagen table.
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    K Number
    K130083
    Device Name
    DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2013-07-17

    (184 days)

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

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Demetech Absorbable Poliglecaprone 25 Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery and neurological tissue.
    Device Description
    DemeCAPRONE (Poliglecaprone 25) is a synthetic monofilament absorbable surgical suture composed of Poly (glycolic-co-caprolactone) copolymer (PGCL) and is supplied un-dyed and dyed with D&C Violet #2 below 0.1wt%. DemeCAPRONE (Poliglecaprone 25) synthetic absorbable suture is available in sizes 6-0 through 1 (metric sizes 0.7 - 4). DemeCAPRONE (Poliglecaprone 25) Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures except for diameter.
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    K Number
    K082097
    Device Name
    DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2010-01-08

    (533 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft . tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
    Device Description
    Demetech's Polydioxanone is a synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) and is supplied un-dyed violet with D & C violet #2. Demetech's Polydioxanone surgical sutures meet the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures.
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    K Number
    K072930
    Device Name
    DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2008-04-30

    (197 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Demetech Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures".
    Device Description
    Demetech Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
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    K Number
    K043330
    Device Name
    POLYPROPILENE SURGICAL SUTURES
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2005-05-16

    (165 days)

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

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures.
    Device Description
    The DemeTECH polypropylene sutures are inert, non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polylefin. The suture is pigmented to enhance visibility.
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    K Number
    K043539
    Device Name
    DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2005-04-06

    (105 days)

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

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.
    Device Description
    Polyglycolic Acid (PGA) is a sterile absorbable synthetic, multifilament suture composed of glycolic acid. The yarns are braided and coated with a blend of polycaprolate, copolymer of caprolactone and glycolide. The PGA Suture is available in violet from sizes: USP8/0 USP2. PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures.
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    K Number
    K023028
    Device Name
    DEMETECH NYLON NONABSORBABLE SUTURE
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2003-06-18

    (280 days)

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

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DemeTECH Nylon Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
    Device Description
    The DemeTECH Nylon Nonabsorbable Suture is a single use, individually packaged, disposable nonabsorbable nylon (polyamide) surgical suture.
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    K Number
    K023030
    Device Name
    DEMETECH POLYESTER NONABSORBABLE SUTURE
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2003-06-18

    (280 days)

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

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
    Device Description
    The DemeTECH Polyester Nonabsorbable Suture is a braided green, individually packaged nonabsorbable Polyester surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes.
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    K Number
    K023029
    Device Name
    DEMETECH SILK NONABSORBABLE SUTURE
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2002-11-25

    (75 days)

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

    DEMETECH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DemeTECH Silk Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
    Device Description
    The DemeTECH Silk Nonabsorbable Suture is a black braided, individually packaged nonabsorbable silk surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes or supplied without needles.
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