# K210087: Athena Surgical RMUS System

- Pathway: 510(k) (Traditional)
- Applicant: Athena Surgical, LLC
- Decided: Apr 12, 2021 after 89 days
- Product code: OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K974098 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132054: Gynecare TVT Exact Continence System, ETHICON, Inc. (2013) Summary page 4.

## Indications for 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.

Source page: https://510kreport.com/device/K210087
Methodology: https://510kreport.com/methodology