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510(k) Data Aggregation
K Number
K130375Device Name
SELF-RETAINING BICANALICULUS INTUBATON SET II
Manufacturer
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
Date Cleared
2013-12-04
(293 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bicanalicular intubation is indicated in treatments of epiphora in adults. Indications for bicanalicular intubation performed with the Self-Retaining Bicanaliculus Stent II are:
- . Punctal stenosis
- . Canalicular stenosis within the lacrimal drainage system
Device Description
The Self-Retaining Bicanaliculus Intubation Set II is a bicanalicular intubation device for the treatment of epiphora in adults. The device consists of two silicone anchors connected to a silicone body that is delivered pre-mounted on two guides and packaged with a disposable dilator. The guides facilitate insertion of the Self-Retaining Bicanaliculus Intubation Set II and are completely removed once insertion of the device is complete. The Self-Retaining Bicanaliculus Intubation Set II comes in three different model lengths (25, 30, or 35 mm depending on length of tube required) and is provided as a sterilized product.
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K Number
K121142Device Name
CRAWFORD BIOCANALICULUS INTUBATION
Manufacturer
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
Date Cleared
2012-08-09
(115 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Crawford Bicanaliculus Intubation stents are intended for use for nasolacrimal intubation in patients 12 months of age and older. Indications for nasolacrimal intubation performed with the Crawford Bicanaliculus Intubation are:
- . Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
- During dacryocystorhinostomy .
- Congenital lacrimal duct obstruction .
Device Description
The Crawford Bicanaliculus Intubation is a bicanalicular intubation device that consists of a silicone tube that is attached at each end to a flexible metallic Crawford probe. The Crawford Bicanaliculus Intubation comes in a single length of 310 mm and is provided as a sterilized product.
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K Number
K113536Device Name
MASTERKA 40 MASTERKA 35 MASTERKA 30
Manufacturer
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
Date Cleared
2012-08-03
(247 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MASTERKA® is a silicone intubation device indicated for use in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older.
Device Description
The MASTERKA® is a monocanalicular intubation device with self-retaining punctal fixation for the treatment of stenoses that require intubation. The device consists of a silicone tube molded to a fixation head and pre-mounted on an introducer facilitates insertion of the MASTERKA and is completely removed once the intubation of the lacrimal passages has been completed. The MASTERKA® comes in three different lengths (30, 35, or 40 mm depending on the model) and is provided as a sterilized product.
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