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510(k) Data Aggregation

    K Number
    K233265
    Device Name
    Monotime and Optime R
    Manufacturer
    Peters Surgical
    Date Cleared
    2024-10-11

    (378 days)

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

    Peters Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.
    Device Description
    OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery. These sutures are available with a disposable needle attachment. OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
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    K Number
    K232372
    Device Name
    Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
    Manufacturer
    Peters Surgical
    Date Cleared
    2024-07-12

    (339 days)

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

    Peters Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery, and neurological tissue.
    Device Description
    ADVANTIME® sutures are intended to be used in suturing and/or tissue ligation in open or laparoscopic surgery. These sutures are available with a disposable needle attachment. ADVANTIME® is a single use, sterile, single-stranded (monofilament), synthetic bioabsorbable thread made of a poliglecaprone (a copolymer of glycolide and E- caprolactone of low tissue reactivity). Sutures are commonly used in digestive, urological, aesthetic, gynecological and intradermal surgery. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. The same applies to double-armed needles. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
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    K Number
    K071281
    Device Name
    UNIRING - ANNULOPLASTY RING WITH SIZERS
    Manufacturer
    PETERS SURGICAL
    Date Cleared
    2007-08-03

    (88 days)

    Product Code
    KRH
    Regulation Number
    870.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PETERS SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIRING® is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
    Device Description
    The UNIRING® consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available scparately to properly size the annulus.
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    K Number
    K060465
    Device Name
    PREMIO
    Manufacturer
    PETERS SURGICAL
    Date Cleared
    2007-01-17

    (329 days)

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

    PETERS SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
    Device Description
    PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.
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    K Number
    K060163
    Device Name
    CARDIOFLON, CARDIOXYL
    Manufacturer
    PETERS SURGICAL
    Date Cleared
    2006-10-11

    (261 days)

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

    PETERS SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CARDIOFLON® and CARDIOXYL® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
    Device Description
    The synthetic non-absorbable surgical sutures CARDIOFLON® and CARDIOXYL® are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOFLON® braids are coated with a polymer of tetrafluorethylene (PTFE) and CARDIOXYL® braids are coated with polysiloxane. CARDIOFLON® and CARDIOXYL® sutures are green dyed (D&C green nº6 CI 61565) and white (undyed). Some packs are composed of green and white II is to facilitate location during use. CARDIOFLON® and CARDIOXYL® sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for nonabsorbable surgical sutures.
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    K Number
    K062366
    Device Name
    OPTIME, SINUSORB PGA
    Manufacturer
    PETERS SURGICAL
    Date Cleared
    2006-10-02

    (49 days)

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

    PETERS SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The synthetic absorbable surgical sutures OPTIME® and SINUSORB® PGA are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery; but not for use in cardiovascular and neurological surgery.
    Device Description
    OPTIME® and SINUSORB® PGA are synthetic absorbable braids composed of homopolymer of glycolic acid and coated with epsilon-caprolactone and calcium stearate or a mixture composed of polycaprolacton, calcium stearate and fatty acid ester. These surgical sutures are available undyed or violet dyed with an FDA approved color additive: D&C violet nº2, CI 60725. The suture may be provided with or without a standard needle attached.
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    K Number
    K052701
    Device Name
    COROLENE
    Manufacturer
    PETERS SURGICAL
    Date Cleared
    2005-12-13

    (76 days)

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

    PETERS SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery.
    Device Description
    COROLENE® is a monofilament synthetic non-absorbable surgical suture composed of polypropylene. The suture is available undyed or blue dyed with an FDA approved color additive: Phtalocyanine-copper (CI 74160), to enhance visibility. The suture may be provided with or without a standard needle attached.
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