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510(k) Data Aggregation

    K Number
    K201892
    Device Name
    Ritleng®+ and Ritleng®+ PVP
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2021-03-11

    (246 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RITLENG®+ products are indicated in the treatment of 12 months and older in cases of: - Canalicular pathologies (stenoses, obstructions, lacerations), - Congenital duct obstruction (Hasner valve stenosis), - Dacryocystorhinostomy (conventional or laser).
    Device Description
    The RITLENG®+ is a self-retaining nasal bicanalicular intubation for the lacrimal ducts. It consists of a silicone tube with two larger diameter portions, connected at each extremity with a PEEK thread guide. Each thread guide has a wide diameter part and a narrow diameter part. The silicone tube may be coated with polyvinylpyrrolidone (PVP) to improve its wettability. The central body of the intubation displays a marking intended for the intubation placement between the lacrimal puncta.
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    K Number
    K201606
    Device Name
    LacriJet®
    Manufacturer
    FCI (France Chirurgie Instrumentation) SAS
    Date Cleared
    2020-12-18

    (186 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LACRIJET® from 30 to 50 mm are indicated in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older. LACRIJET® with small size (15/20 mm) are indicated in the repair of canalicular lacerations.
    Device Description
    LacriJet® is a monocanalicular intubation device, with self-retaining punctal fixation for the treatment of monocanalicular lacerations and stenoses. The silicone stent acts as a conformer. The shape of the fixation head keeps the probe from migrating and from expulsing.
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    K Number
    K170247
    Device Name
    Lacriflow CL
    Manufacturer
    KANEKA PHARMA AMERICA LLC
    Date Cleared
    2017-04-18

    (81 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction.
    Device Description
    The LACRIFLOW CL is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW CL consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site.
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    K Number
    K161373
    Device Name
    Nunchaku
    Manufacturer
    FCI (FRANCE CHIRURGIE INSTRUMENTATION)
    Date Cleared
    2016-11-03

    (170 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nunchaku stents are intended for use for nasolacrimal intubation in patients 12 months and older. Indications for nasolacrimal intubation performed with the Nunchaku are: - Canalicular pathologies (e.g., congenital or acquired stenosis, laceration) - During dacryocystorhinostomy - Congenital lacrimal duct obstruction
    Device Description
    The Nunchaku is a bicanalicular intubation device for the treatment of epiphora in patients 12 months and older. The device consists of two lateral silicone tubes connected to a silicone body that is delivered pre-mounted on two guides facilitate insertion of the Nunchaku and are completely removed once insertion of the device is complete. The Nunchaku comes in two different model lengths (90 or 105 mm depending on length of tube required) and is provided as a sterilized product.
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    K Number
    K160710
    Device Name
    Oasis Lacrimal Intubation Set
    Manufacturer
    ANODYNE
    Date Cleared
    2016-05-13

    (59 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oasis Medical Lacrimal Intubation Set is intended for use for nasolacrimal intubation in patients of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are: - · Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations) - · During dacryocystorhinostomy - · Congenital lacrimal duct obstruction
    Device Description
    The Oasis Lacrimal Intubation Set with Retrieval Device (Model Summary: 6004) is a sterile (via gamma sterilization-VDmax method-25kGy), single-use, hand held, and ophthalmic surgical device. The device consists of a twelve inch medical grade silicone tube that is secured at each end to two 4 ½", 23 gauge stainless steel, olivetipped probes along with a 3″ plastic handled retriever with a stainless steel hook. The Oasis Lacrimal Intubation Set with Retrieval Device is used by a physician for nasolacrimal intubation.
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    K Number
    K142914
    Device Name
    DacryoCATH
    Manufacturer
    ARMADILLO BIOMEDICAL, LLC
    Date Cleared
    2015-01-12

    (97 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations: a. The 2MM catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age. b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age. c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.
    Device Description
    The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and nylon balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.
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    K Number
    K140290
    Device Name
    STOPLOSS JONES TUBE
    Manufacturer
    LJT SURGICAL LTD
    Date Cleared
    2014-12-02

    (300 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StopLoss Jones tube system is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.
    Device Description
    The StopLoss Jones Tube assembly consists of a flanged glass tube and silicone washer. The glass tube is Pyrex borosilicate glass and the silicone is NuSil. It is offered in a range of sizes as follows: ID 1.15 -1.25mm OD 1.90 - 2.10mm Lengths 9-22mm +/-0.5mm in 1mm increments The device is provided sterile for single use only.
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    K Number
    K130375
    Device 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/A
    Why did this record match?
    Product Code :

    OKS

    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
    K123831
    Device Name
    OPHTACATH KIT
    Manufacturer
    FRANCE CHIRURGAE INSTRUMENTATION
    Date Cleared
    2013-07-29

    (229 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OphtaCath® Unilateral Kits (2-mm and 3-mm) are intended for use during dilation of the obstructed nasolacrimal duct to treat epiphora. For patients older than 12 months but under 30 months, the recommended catheter is the 2 mm balloon diameter. For patients 30 months and older, the recommended catheter is the 3 mm balloon diameter.
    Device Description
    The OphtaCath® lacrimal duct catheter is a sterile and single-use balloon catheter consisting of a semi-flexible stainless steel stylet covered by PBX tubing that ends with a nylon balloon. The balloon is covered by a protective polyethylene sleeve. The balloon is designed to be inflated to a known diameter and length at the specified pressure. Markings are placed at 10 mm and 15 mm · proximal to the working portion of the balloon. The overall length of the catheter is approximately 240 mm long. The catheter is available in a 2 mm inflated diameter. The 2 mm balloon has a length of 13 mm and a diameter of 0.90 mm before inflation. The 3 mm balloon has a length of 15 mm and a diameter of 1.0 mm before inflation. The Flamingo Inflation Device is an accessory to the OphtaCath®, and is a sterile, single-use inflation device for dilating the balloon catheter, monitoring balloon pressure, and deflating the balloon postoperatively. The OphtaCath® is sold as a unilateral kit that contains one 2 mm or 3 mm balloon catheter and an inflation device (OphtaCath® Unilateral Kits, 2-mm and 3-mm).
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    K Number
    K120886
    Device Name
    LACRIFAST
    Manufacturer
    HIROYASU HIGUCHI
    Date Cleared
    2012-12-17

    (269 days)

    Product Code
    OKS, LAC
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    OKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LACRIFLOW is indicated in treatments of epiphora in patients 12 months and older, in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction.
    Device Description
    The LACRIFLOW is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the insertion of the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site.
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