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510(k) K210087

Athena Surgical RMUS System by Athena Surgical, LLC — Product Code OTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2021
Date Received
January 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

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