# K231786: Gynethotics™ Pessary

- Pathway: 510(k) (Traditional)
- Applicant: Cosm Medical
- Decided: Mar 6, 2024 after 260 days
- Product code: HHW (Pessary, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974116 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013289: Bioteque Vaginal Pessaries, Bioteque America, Inc. (2001) Summary page 5.
- K092981: Panpac Vaginal Pessary, Panpac Medical Corporation (2010) Summary page 5.
- K173351: Panpac Flexi Shelf Pessary, Panpac Medical Corporation (2018) Summary page 5.
- K974116: Pelvx Incontinence Ring, Deschutes Medical Products, Inc. (1998) Summary page 5.

## Indications for use
Gynethotics Ring Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse. Gynethotics Ring with Support Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse. Gynethotics Ring with Knob Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Ring with Support and Knob is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Incontinence Ring Pessary is indicated for use in cases of stress urinary incontinence. Gynethotics Marland Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Marland with Support Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Gellhorn Pessary is indicated for use in cases of mild (Stage I) to severe (Stage III or procidentia) pelvic organ prolapse. Gynethotics Cube Pessary is indicated for use in cases of moderate (Stage II) to severe (Stage III or procidentia) pelvic organ prolapse.

Source page: https://510kreport.com/device/K231786
Methodology: https://510kreport.com/methodology