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510(k) Data Aggregation
K Number
K230730Device Name
Apyx
Manufacturer
Escala Medical
Date Cleared
2023-07-25
(131 days)
Product Code
PBQ
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
Escala Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
Device Description
The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor / suture assembly is deployed to the target site from the cartridge with an applicator. An optional use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing.
The Apyx device is a single use device which is supplied sterile.
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K Number
K213783Device Name
Apyx
Manufacturer
Escala Medical
Date Cleared
2022-04-05
(123 days)
Product Code
PBQ
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
Escala Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
Device Description
The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor/suture assembly is deployed to the target site from the cartridge with an applicator. An optional retriever can be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx device is a single use device which is supplied sterile.
Ask a Question
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