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510(k) Data Aggregation
K Number
K210087Device Name
Athena Surgical RMUS System
Manufacturer
Athena Surgical, LLC
Date Cleared
2021-04-12
(89 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Athena Surgical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Athena Surgical RMUS System is indicated for use as a pubourethral sling for treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description
The Athena Surgical RMUS System consists of a sterile, single-use Retropubic Mid-Urethral Sling (RMUS) Implant Assembly and a non-sterile, reusable RMUS Handle Assembly. Each RMUS Implant Assembly contains one blue polypropylene mesh sling implant (1.1cm x 46cm), covered by a non-implantable clear plastic sheath and attached on each end to nonimplantable stainless steel needles. The mesh implant is constructed of knitted filaments of extruded polypropylene strands and is approximately 0.63mm thick. The Athena Surgical RMUS Implant Assembly is designed to be used with the non-sterile, reusable Athena Surgical RMUS Handle Assembly, which consists of two parts: the Handle Body and the Handle Insert. The stainless steel needles from the RMUS Implant Assembly are designed to fit inside the RMUS Handle Assembly, which is used to position the implantable mesh in the patient from a vaginal incision up through the abdominal wall.
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