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510(k) Data Aggregation

    K Number
    K071406
    Device Name
    AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2007-11-21

    (184 days)

    Product Code
    FZP, GDO
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto Suture™ Endo Clip III™ 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic markings.
    Device Description
    The Autosuture™ ENDO CLIP™ III 5mm Clip Applier contains 18 titanium clips. The applier is designed for introduction and use through an appropriately sized Trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.
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    K Number
    K071920
    Device Name
    AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2007-09-28

    (78 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syneture™ Absorbable Tack and Applicator are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
    Device Description
    The Syneture™ Absorbable Tack and Applicator are sterile single use devices for the fixation of prosthetic material, such as hernia mesh, onto soft tissue. The Absorbable Tack is formed from synthetic polyester derived from a lactic acid and glycolic acid copolymer. The Applicator is offered with a range of 5 to 20 tacks.
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    K Number
    K061288
    Device Name
    AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2006-11-02

    (177 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier has applications in many types of endoscopic procedures to achieve hemostasis following transection of vessels and other tubular structures, and for radiographic markings.
    Device Description
    The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.
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    K Number
    K062850
    Device Name
    AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2006-10-23

    (28 days)

    Product Code
    GDW, GAG
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The autosuture™ Circular EEA™ Staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
    Device Description
    The autosuture™ Circular EEA™ family of staplers place a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
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    K Number
    K062326
    Device Name
    AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2006-09-01

    (23 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
    Device Description
    The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is available in 5 mm short length, 5 mm regular length, 11 mm regular length, 12 mm regular length, and 12 mm long length sizes. The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve has a sharp linear blade with a spring- loaded locking shield. Upon entry into a free space the shield advances to cover the blade, reducing the potential for injury to internal structures. The trocar sleeve contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The VERSASEAL™ self-adjusting seal accommodates instruments ranging from 5 mm to 12 mm and is designed to effectively reduce the seal diameter to allow insertion of smaller instruments. There is a stopcock valve for insufflation and rapid desufflation.
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    K Number
    K061095
    Device Name
    AUTO SUTUR ENDO GIA STAPLERS
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2006-05-31

    (42 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto Suture™ ENDO GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
    Device Description
    The Auto Suture™ ENDO GIA™ Stapler places two, triple- staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm 3.5 mm or 4.8 mm single-use loading unit (SULU). The ENDO GIA™ Stapler will accommodate any of the single-use loading units that are available in 30 mm, 45 mm and 60 mm sizes.
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    K Number
    K050947
    Device Name
    MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2005-06-01

    (47 days)

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

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Modified USS polypropylene sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
    Device Description
    Modified USS Polypropylene Suture is composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.
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    K Number
    K042412
    Device Name
    MODIFIED SPACEMAKER SYSTEM
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2004-09-24

    (17 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified SPACEMAKER* System: SPACEMAKER* Structural Balloon Trocar The SPACEMAKER* Structural Balloon Trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures. SPACEMAKER* Blunt Tip Trocar The SPACEMAKER* Blunt Tip Trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery. SPACEMAKER* Dissection Balloon The SPACEMAKER* Dissection Balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
    Device Description
    The Modified SPACEMAKER* System consists of a balloon dissector and trocar which are used in conjunction to provide a port of access and tissue separation during laparoscopic surgery.
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    K Number
    K040594
    Device Name
    HERCULON SOFT TISSUE REATTACHMENT SYSTEM
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2004-03-31

    (23 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Herculon* Soft Tissue Reattachment System is indicated for the reapproximation of soft tissue.
    Device Description
    The Herculon* Soft Tissue Reattachment System is a nonabsorbable repair device used to attach soft tissue to bone using sutures. The device is a self tapping, Ti-6Al-4V threaded implant that accommodates one or two sutures. The sterile package includes a Suture Anchor, Inserter, and polyester suture.
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    K Number
    K032696
    Device Name
    AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    2003-12-01

    (90 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.
    Device Description
    The Auto Suture* TA* & GIA* Staplers are designed to place multiple staggered rows of titanium or stainless steel staples in various types of tissues.
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