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510(k) Data Aggregation

    K Number
    K061651
    Device Name
    FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    2006-10-20

    (129 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.
    Device Description
    Not Found
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    K Number
    K050256
    Device Name
    APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    2005-04-26

    (82 days)

    Product Code
    GAD, KNA
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in nonurgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.
    Device Description
    The Apple Medical OB/Mobius® Elastic Retractor is a sterile disposable abdominal retractor consisting of two flexible plastic rings connected by a sleeve of soft, high yield strength, clear plastic film. The internal ring has a circular cross-section (o-ring) and the external ring has a cruciform cross-section (quad-ring). The inner diameter of the internal o-ring limits the radius of abdominal retraction. The diameter of the external quad-ring is the same as the diameter of the internal o-ring and the sleeve. When completely unwound, the height of the cylinder is 10.6 inches. When the quad ring is rolled down, the sleeve is wrapped around the circumference of the ring reducing the height of the sleeve by 1.5 inches per rotation. Because the sleeve film is radially unyielding, the reduction in height causes the radial retraction of the incision site.
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    K Number
    K041131
    Device Name
    APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    2004-05-13

    (13 days)

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

    APPLE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apple Medical OB Mobius Elastic Retractor is indicated for use to assist in laparotomy procedures. It is intended to provide incision retraction and to protect against wound contamination during open surgery.
    Device Description
    The Apple Medical OB Mobius Elastic Retractor is used for laparotomy procedures where a transverse suprapubic incision is made in the abdominal wall allowing access to the peritoneal cavity. Once the incision is made, the internal o-ring is manually collapsed and inserted through the abdominal incision where it is allowed to spring open against the parietal peritoneum. The external quad-ring is then pulled upward placing the cylindrical sleeve in tension and the operator rolls the ring down the sleeve until the ring sits firmly against the skin. The radial force of the two rings act to retract the abdominal wall to the desired circular geometry.
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    K Number
    K014005
    Device Name
    APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    2002-02-15

    (72 days)

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

    APPLE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apple Medical Mobius Elastic Retractor is indicated for use to assist in minilaparotomy incision retraction and to protect against wound contamination during open surgery.
    Device Description
    The Apple retractor is used for minilaparotomy procedures where a transverse suprapubic incision is made in the abdominal wall allowing access to the peritoneal cavity. Once the incision is made, the internal om and aboundar wan and inserted through the abdominal incision where it is allowed to spring open against the parietal peritoneum. The external quad-ring is then pulled upward placing the cylindrical sleeve in tension and the operator rolls the ring down the sleeve until the ring sits firmly against the skin (ref. Directions for Use). The radial force of the two rings place the sleeve material in tension and the sleeve now acts to retract the abdominal wall to the desired circular geometry. Both the proposed Apple device and the predicate Dexterity device function in an identical way to retract the abdomen. The difference in the two devices is in the ergonomical efficiency of deploying the two devices. The external quad-ring of the proposed Apple device was engineered to have more points around the 360 degree circumference for increased tactile manipulation ability (the predicate has two points in an "oblate spheroid" type of crosssection and the Apple device has four points in a truncated astroid, or "cruciform", cross-section). Further, the Apple device's external quad-ring is formed into a mobius strip during fabrication thus imparting a preset outward torque on the device. This "mobius" type of fabrication coupled with the four points for tactile feel, results in an external quad-ring which is easier to manipulate into the desired position than is the recircate device while still possessing an equivalent resistance to rollback as the predicate.
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    K Number
    K000026
    Device Name
    APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    2000-03-31

    (86 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970788
    Device Name
    PNEUMO-MATIC INSUFFLATION NEEDLE
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    1997-03-27

    (23 days)

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

    APPLE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "window" and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.
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    K Number
    K961460
    Device Name
    LWEET CONE BIOPSY INSTRUMENT
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    1996-11-19

    (217 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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