Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K213475
    Device Name
    Elevo Snoring Intervention Set
    Manufacturer
    Date Cleared
    2022-01-27

    (90 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zelegent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Elevo® Snoring Intervention Set is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals.
    Device Description
    The Elevo® Snoring Intervention Set is comprised of three (3) sterile, absorbable, barbed, poly(L-lactide-co-D L-lactide) sutures and three (3) corresponding disposable, sterile, single use suturing needles. A silk disposable tension suture (DTS) is attached to the proximal end of each of the poly(L-lactide-co-D L-lactide) barbed suture implants. The proximal end of the DTS is secured to the suturing needle handle during device assembly. One (1) Pilot Hole Initiation Tool (PHIT) completes the contents of the set.
    Ask a Question

    Ask a specific question about this device

    K Number
    K181107
    Device Name
    Elevo® Kit Snoring Intervention Device
    Manufacturer
    Date Cleared
    2018-12-06

    (224 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zelegent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Elevo® Kit Snoring Intervention Device is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals. Indications for use of the Elevo® Kit Snoring Intervention Device include symptomatic, habitual, and social snoring due to palatal flutter.
    Device Description
    The Elevo® Kit Snoring Intervention Device is comprised of three (3) sterile, absorbable, and barbed, polydioxanone (PDO) sutures and three (3) corresponding disposable, sterile, single use suturing needles. A disposable tension suture (DTS) is attached to the proximal end of each of the barbed PDO suture implants. The proximal end of the DTS is secured to the suturing needle handle during device assembly.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1