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510(k) Data Aggregation
K Number
K213475Device Name
Elevo Snoring Intervention Set
Manufacturer
Date Cleared
2022-01-27
(90 days)
Product Code
Regulation Number
872.5570Why 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.
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K Number
K181107Device Name
Elevo® Kit Snoring Intervention Device
Manufacturer
Date Cleared
2018-12-06
(224 days)
Product Code
Regulation Number
872.5570Why 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.
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