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510(k) Data Aggregation

    K Number
    K221356
    Device Name
    Wee Bell
    Manufacturer
    wee MEDICAL
    Date Cleared
    2023-02-02

    (268 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.
    Device Description
    The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only. The wee Bell is designed to assist in the performance of a circumferential crushing of the foreskin (prepuce) by tightening the ligature around the bell portion of the device. The remaining foreskin is then removed. The wee Bell is comprised of two components: a transparent plastic bell and a ligature. It is available in six (6) sizes to accommodate anatomy variation in the size of newborn and infant glands. The device is EtO sterilized and is a single-use device.
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    K Number
    K212911
    Device Name
    Konig Mogen Clamp
    Manufacturer
    Medline Industries, Inc
    Date Cleared
    2022-11-18

    (431 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
    Device Description
    The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only. The Konig Mogen Clamp consists of an arm with a locking mechanism in order facilitate compression on the foreskin. The locking mechanism consists of a lock connected to a lock bar using a pin. The clamp is fixed with a spot welding point, which allows for a maximum opening of 2.5 mm. The edges of the closing area are chamfered and rounded to avoid tissue injury. The Konig Mogen Clamp is a reusable instrument that is provided non-sterilyzed by the user. The Konig Mogen Clamp will be validated for use in pre-vacuum steam sterilization.
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    K Number
    K151095
    Device Name
    Circumplast Circumcision Device
    Manufacturer
    Novadien Healthcare
    Date Cleared
    2015-09-18

    (148 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Circumplast single use circumcision device is intended to be used to perform circumcisions on infant males. This device consists of two components: Circumplast Circumcision Device and Ligature. The Ligature was tested for use with Circumplast Circumcision Device only.
    Device Description
    The Circumplast is a device composed of two components, a transparent plastic conic tube, and a linen ligature. The device is sold sterile for single use, packaged in a sterile pouch. The Circumplast is available in four (4) sizes, to accommodate size of the infant's penis. The Circumplast is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare Practitioner fixes the patient's foreskin over the inner ring and then the prepuce is tied all around, over the groove of the bell, with a tight ligature. Skin forward of the crush line is trimmed away. After the procedure, the Circumplast device remains on the patient for 7 days. The Circumplast falls off after 3 - 7 days.
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    K Number
    K142163
    Device Name
    MALE CIRCUMCISION KITS:RAPIDECLAMP
    Manufacturer
    MEDICFIT TECHNOLOGY SDN BHD
    Date Cleared
    2015-04-20

    (257 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Circumcision of foreskin of males from infant to adult by circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
    Device Description
    The Male Circumcision Kits: RAPIDECLAMP™ is a surgical procedure purposely for circumcision which using a set of clamps that involves partial or complete removal of the foreskin (prepuce) of the penis. This device was designed technologically using molding process to replace the conventional method. It was designed specifically to promote faster circumcision process, prevent severe bleeding with less pain. It contains a set of clamp with a protective shield, RAPIDECLAMP™ measuring plate, and a blade or scissor. This device known as RAPIDECLAMP™ is made up of Polycarbonate (PC) and Acrylonitrile butadiene styrene (ABS). Generally, RAPIDECLAMP™ consists of Guide Ring, Spike Body-Front and Rear, Anti-Slip Ring, Locking Cover, and Protective Shield.
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    K Number
    K131373
    Device Name
    SHANGRING
    Manufacturer
    WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY
    Date Cleared
    2013-06-25

    (43 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ShangRing™ Circumcision Clamp intended use is for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.
    Device Description
    Not Found
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    K Number
    K121789
    Device Name
    SHANGRING
    Manufacturer
    WUHU SNNA MEDICAL TREATMENT APPLIANCE TECHNOLOGY C
    Date Cleared
    2012-08-03

    (45 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ShangRing™ device is indicated for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.
    Device Description
    The ShangRing is a sterile, single use, disposable circumcision device consisting of two concentric rings made from polycarbonate. The outer ring is formed from two semi-circular halves that are joined together on one end by a hinge, and by interlocking ratchets on the opposite end. The inner ring is lined with a soft silicone band. The ShangRing is available in 14 sizes with inner ring diameters ranging from 26mm to 40mm. A disposable sizing guide is provided to assist in selecting the appropriate size ShangRing. The ShangRing is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare practitioner everts the patient's foreskin over the inner ring and the outer ring halves are locked together, sandwiching the foreskin between the two rings which effectively prevents bleeding. Skin forward of the crush line is trimmed away. After the procedure, the ShangRing device remains on the patient for 7 days. After 7 days, the ShangRing is removed by the healthcare practitioner.
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    K Number
    K103695
    Device Name
    PREPEX SYSTEM
    Manufacturer
    CIRC MEDTECH
    Date Cleared
    2012-01-10

    (389 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PrePex is indicated for circumcision of adult males. Prepex is intended to be placed and removed by a health care professional trained in male circumcision and in use of the PrePex device.
    Device Description
    The PrePex is a device composed of three components; a plastic Inner Ring, an Elastic outer clamping Ring and a Placement Ring for applying the clamping Elastic Ring. The PrePex System is sold sterile for single use and is available in multiple sizes to accommodate variances in adult patients. A sizing guide is separately available, sold clean for single use
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    K Number
    K100916
    Device Name
    MEDICON MOGEN CLAMP
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2010-12-06

    (248 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medicon Mogen Circumcision Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child.
    Device Description
    The Medicon Mogen Circumcision Clamp is a stainless steel, reusable circumcision clamp consisting out of multiple components, including clamp and locking bar. For safety reasons the lock screw of the clamp is fixed with a spot welding point in order not to become loose. For safety reasons the clamp opens to a maximum of 2.5 mm, in order not to trap the glans and the edges of closing area are chamfered and rounded inside and outside to avoid injuries
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    K Number
    K061539
    Device Name
    GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Date Cleared
    2007-09-20

    (472 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used to grasp, crush and cut the penile foreskin on full term, newborn (up to 10 days) male infants.
    Device Description
    AccuCirc Circumcision clamp/cutter
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    K Number
    K063429
    Device Name
    GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
    Manufacturer
    GENERIC MEDICAL DEVICE, INC.
    Date Cleared
    2007-01-17

    (65 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
    Device Description
    The GMD Circumcision Clamp is a stainless steel reusable medical device intended to be used in circumcision procedures. The GMD Circumcision clamp will be sold non-Sterile.
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