# K020007: Safyre Sling System

- Pathway: 510(k) (Traditional)
- Applicant: Promedon
- Decided: Mar 21, 2002 after 78 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: 1 generation back to K974098 (1998). 3 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011251: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K974098: Pubouurethral Sling, ETHICON, Inc. (1998) Summary page 1.
- K010533: Biosling - Bioabsorbable Polymer Sling & Surgical Mesh, Injectx, Inc. (2001) Summary page 1.

## Most influential descendants
- K023898: Gyne Ideas Minitape RP Device (2003), 4 descendants of its own
- K073646: Minitape Urethral Sling (2008), 2 descendants of its own
- K091180: Minitape Urethral Sling (2009), 1 descendant of its own
- K073647: Minitape Extra Urethral Sling (2008), 1 descendant of its own
- K092233: Surgimesh XD (2010), 0 descendants of its own

## Indications for use
Safyre Sling is 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/K020007
Methodology: https://510kreport.com/methodology