# K033691: Safyre VS and Safyre T

- Pathway: 510(k) (Special)
- Applicant: Promedon
- Decided: Dec 19, 2003 after 25 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: 2 generations back to K974098 (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)
- K020007: Safyre Sling System, Promedon (2002) Summary page 1.

## Indications for use
SAFYRE VS and SAFYRE T are to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.

Source page: https://510kreport.com/device/K033691
Methodology: https://510kreport.com/methodology