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Found 13 results
510(k) Data Aggregation
K Number
K093863Device Name
EPIDRUM
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
2010-05-10
(144 days)
Product Code
FMF
Regulation Number
880.5860Why 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
K990366Device Name
EXMOOR SUCTION CLEARANCE KIT
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1999-03-05
(28 days)
Product Code
LRC
Regulation Number
874.4420Why 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
K980828Device Name
EXMOOR MYRINGOTOMY KIT
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1998-10-22
(233 days)
Product Code
ETD
Regulation Number
874.3880Why 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
K981143Device Name
DILKES LASER/SUCTION CANNULAE
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1998-09-14
(168 days)
Product Code
GEX
Regulation Number
878.4810Why 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
K972700Device 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
874.3620Why 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
K981088Device Name
MILLS COLUMELLA PROSTHESIS
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1998-06-05
(72 days)
Product Code
ETA
Regulation Number
874.3495Why 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
K981045Device Name
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1998-05-20
(61 days)
Product Code
ETB
Regulation Number
874.3450Why 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
K974008Device Name
PFLEIDERER'S INTRATYMPANIC CATHETER
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1998-05-13
(208 days)
Product Code
ETD
Regulation Number
874.3880Why 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
K974224Device Name
ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1998-01-27
(78 days)
Product Code
ESZ
Regulation Number
874.3820Why 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
K973587Device Name
EXMOOR TYMPANOCENTESIS KIT (TK/1)
Manufacturer
EXMOOR PLASTICS LTD.
Date Cleared
1998-01-23
(123 days)
Product Code
JZF
Regulation Number
874.4420Why 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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