# K121928: Desara SL

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Feb 19, 2013 after 232 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: 6 generations back to K974098 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112609: Desara Mesh, Caldera Medical, Inc. (2011) Summary page 1.
- K100936: Gynecare TVT Abbrevo Continence System, ETHICON, Inc. (2010) Summary page 1.

## Indications for use
Desara SL is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K121928
Methodology: https://510kreport.com/methodology