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510(k) Data Aggregation

    K Number
    K093863
    Device Name
    EPIDRUM
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    2010-05-10

    (144 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epidrum is intended for use in epidural procedures between a luer syringe and an epidural needle to give a clear visual signal that the needle tip has entered the epidural space. The Epidrum is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space.
    Device Description
    The Epidrum comprises a small chamber, featuring a female Luer inlet port and a male Luer exit port on opposing sides, with an expandable membrane as one of the sides between the ports. The Epidrum is a single use device, manufactured from medical grade polymers.
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    K Number
    K990366
    Device Name
    EXMOOR SUCTION CLEARANCE KIT
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1999-03-05

    (28 days)

    Product Code
    LRC
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to clean the external ear canal and tympanum. The need to clear and clean the external ear canal.
    Device Description
    Comprehensive, single use, sterile procedure pack comprising: 18 swg fine end 14 swg suction tube Cotton wool mop Wax curette
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    K Number
    K980828
    Device Name
    EXMOOR MYRINGOTOMY KIT
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-10-22

    (233 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Requirement for myringotomy, with or without the insertion of aural ventilation tube(s).
    Device Description
    This single-use device is composed of any combinations of the components included within attachment numbers: 2b, 2c, 2d, 2f, 2h 2, 2a, 2e, 2g. Note: all kits shall contain a myringotome and an instrument for inserting the ventilation tube/ grommet. It has been sterilised by gamma irradiation and is ready for use. The ventilation tubes have been sterilised by steam.
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    K Number
    K981143
    Device Name
    DILKES LASER/SUCTION CANNULAE
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-09-14

    (168 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Any surgical procedure within the nasal cavity, the oral cavity or the oropharynx, which requires laser surgery and suction capability to remove smoke.
    Device Description
    This device is constructed from an Exmoor Single Use Suction Tube (MP17291), 510K 892504, a piece of stainless steel needle tubing (MP170288) identical to that used in MP170291, covered by the same 510K 892504, and a piece of silicone rubber tubing (MP180163) which is used to hold the two pieces of stainless steel tubing together in the correct position. It uses locally supplied suction tubing to connect the device to suction by pushing the tubing over the ball feature at the proximal end of the handle. The laser fibre is passed down the exposed end of the stainless steel tubing adjacent to the handle until it emerges from the distal end. The laser fibre protruding from the distal end of the instrument should be stripped and cleaved and adjusted to the required length.
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    K Number
    K972700
    Device Name
    EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-07-16

    (393 days)

    Product Code
    KHJ
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT This implant is designed to aerate the attic and mastoid antrum following tympanomastoid surgery. This silastic implant is designed to be placed in the attic and back into the mastoid antrum following mastoidectomy/ tympanoplasty surgery. The narrow end is placed under the head of the malleus when present and back into the mastoid antrum to enhance mucosa regrowth. 2. EXMOOR MIDDLE EAR AERATION SHEETING 1. This implant is designed to reduce adhesions in the middle ear following tympanoplasty surgery. 2. Made with medical grade silicone, this implant was designed to be used following middle ear surgery to prevent middle ear adhesions, especially from the malleus to the promontory, or from the ear drum to the inner ear.
    Device Description
    The devices are small, shaped pieces of silicone rubber sheet. They are intended for long term use, i.e. it is not necessary for this material to be removed.
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    K Number
    K981088
    Device Name
    MILLS COLUMELLA PROSTHESIS
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-06-05

    (72 days)

    Product Code
    ETA
    Regulation Number
    874.3495
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mills Columella is intended to improve or restore hearing by replacing an absent or defective incus and stapes. The treatment of an absent or defective stapes.
    Device Description
    The Mills Columella Prosthesis is manufactured from p.t.f.e., a material which has been used for the reconstruction of the middle ear for many years. It can be combined with an ossicular or cortical bone graft for the treatment of ossicular defects, including loss of stapes arch.
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    K Number
    K981045
    Device Name
    EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-05-20

    (61 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This prosthesis can be used to reconstruct an absent or defective stapes and incus.
    Device Description
    The Exmoor Teflon Loop will be offered in two sizes. Each comprises one element, the shaft of which is 6.0mm long and is either 0.4mm or 0.6mm in diameter. The loop has an internal dimension of 0.7mm to fit the malleus for the replacement of the stapes and the incus. Secure closure is provided by "plastic memory". The outside diameter of the loop is either 1.5mm or 1.9mm.
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    K Number
    K974008
    Device Name
    PFLEIDERER'S INTRATYMPANIC CATHETER
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-05-13

    (208 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a closed system for the repeated, safe delivery of therapeutic agents into the middle ear, to facilitate the control of disabling vertigo arising from active unilateral Meniere's Disease. Incapacitating unilateral Menière's Disease
    Device Description
    This single use device consists of a silicone rubber catheter, 21cm in length, with a spring loaded Luer lock at one end and a soft rubber flange, to retain the device in the middle ear, at the other.
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    K Number
    K974224
    Device Name
    ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-01-27

    (78 days)

    Product Code
    ESZ
    Regulation Number
    874.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T' type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura.
    Device Description
    This device is a small, T-shaped piece of silicone rubber sheet, approximately 8.5mm x 1mm x 0.125mm. The T-bar is 5mm wide.
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    K Number
    K973587
    Device Name
    EXMOOR TYMPANOCENTESIS KIT (TK/1)
    Manufacturer
    EXMOOR PLASTICS LTD.
    Date Cleared
    1998-01-23

    (123 days)

    Product Code
    JZF
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXMOOR PLASTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to collect middle ear fluid within the viscosity range of sae 30-50 for laboratory analysis. Requirement for aspiration and analysis of middle ear fluid from behind an intact tympanic membrane (ear drum)
    Device Description
    This single use device is designed to collect specimens of middle ear fluid from behind an intact tympanic membrane and comprises the following: polythene disposal bag, glove (examination), 'Disposafe' (for sharps), fenestrated surgical ear drape, mop, label, vial assembly, suction tube (hand-piece), myringotome (aspirating), specimen bag (laboratory), aural speculum, 2.5mm. It has been sterilized by gamma irradiation and is ready for use.
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