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510(k) Data Aggregation

    K Number
    K233569
    Device Name
    SeptAlign
    Manufacturer
    Spirair, Inc.
    Date Cleared
    2024-03-22

    (137 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
    Device Description
    The Spirair SeptAlign implant is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. SeptAlign is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. SeptAlign is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle to enable attachment to the tissue which is trimmed off affer use. SeptAlignis provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period. The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.
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    K Number
    K223167
    Device Name
    Spirair Nasal Septal Strap
    Manufacturer
    Spirair, Inc.
    Date Cleared
    2023-08-17

    (314 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirair Nasal Septal Strap is used to support and straighten in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
    Device Description
    The Spirair Nasal Septal Strap is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. The Nasal Septal Strap is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. The Nasal Septal Strap is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle attachment to the tissue which is trimmed off after use. The Nasal Septal Strap is provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.
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    K Number
    K210411
    Device Name
    PosiSep EAR Fragmentable Ear Dressing
    Manufacturer
    Hemostasis LLC
    Date Cleared
    2022-05-05

    (448 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery: As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation. PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.
    Device Description
    The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.
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    K Number
    K192661
    Device Name
    LATERA Absorbable Nasal Implant System
    Manufacturer
    Entellus Medical, Inc. (Aka Stryker ENT)
    Date Cleared
    2019-11-10

    (46 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.
    Device Description
    The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16-gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.
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    K Number
    K183015
    Device Name
    PuraSinus
    Manufacturer
    3-D Matrix, Inc.
    Date Cleared
    2019-04-12

    (163 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PuraSinus® is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.
    Device Description
    PuraSinus® is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraSinus® forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue. PuraSinus® is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraSinus® can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.
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    K Number
    K161191
    Device Name
    Latera Absorbable Nasal Implant
    Manufacturer
    SPIROX, INC.
    Date Cleared
    2016-06-23

    (57 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
    Device Description
    The Spirox Latera Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the Latera Absorbable Nasal Implant) and Accessory Delivery Device (Delivery Device). The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and overall length of 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. The Latera Absorbable Nasal Implant and Accessory Delivery Device are provided sterile and are intended for single-use only.
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    K Number
    K152958
    Device Name
    INEX Absorbable Nasal Implant
    Manufacturer
    SPIROX, INC.
    Date Cleared
    2015-12-04

    (58 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirox INEX Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
    Device Description
    The Spirox INEX Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the INEX Absorbable Nasal Implant and accessory Delivery Tool. The implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and an overall length of 24mm. The distal end of the implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Tool is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Tool enables placement of the implant in a minimally invasive manner. The INEX Absorbable Nasal Implant and accessory Delivery Tool are provided sterile and are intended for single-use only.
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    K Number
    K132920
    Device Name
    SPIROX INEX DEVICE
    Manufacturer
    SPIROX, INC.
    Date Cleared
    2014-06-10

    (266 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.
    Device Description
    The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide) 70:30. The product is provided as a perforated sheet comprised of multiple "rod" like elements. The sheet is nominally 24.5 x 20.0 mm with a thickness of 1.1 mm. The bridge sections are nominally 3.0 x 1.9 mm and the voids are nominally 2.4 x 1.9 mm. The implant can be trimmed and shaped to dimensions suitable for the surgical need. The device is implanted using standard surgical tools and techniques The Spirox INEX implantable sheet is a sterile, single use device.
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    K Number
    K122434
    Device Name
    MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
    Manufacturer
    MEDTRONIC XOMED
    Date Cleared
    2012-10-31

    (82 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.
    Device Description
    MeroGel is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel device fills ENT cavities following surgery or trauma to keep tissues or structures separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine ENT surgery. MeroGel leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.
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    K Number
    K092590
    Device Name
    PDS PLATES
    Manufacturer
    ETHICON, INC.
    Date Cleared
    2010-02-17

    (177 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    NHB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ethicon Inc. PDS Flexible Plates are indicated for: – Nasal soft-tissue and cartilage reconstruction
    Device Description
    PDS Flexible Plate are made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerisation of the monomer p-dioxanone. PDS Flexible Plate are dyed with D+C violet # 2 (Color index Number 60725). PDS Flexible Plate are available in various film thicknesses, some of which are also perforated. PDS Flexible Plate can be trimmed to suit the anatomical conditions. The PDS Flexible Plate is a sterile, single use device.
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