# K094061: Kensey Nash Ecm Surgical Patch

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corporation
- Decided: May 18, 2010 after 138 days
- Product code: FTM (Mesh, Surgical)
- 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 K921895 (1992). 34 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 1.
- K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft, Cook Biotech, Inc. (2006) Summary page 1.
- K011025: Fortaflex Surgical Mesh, Organogenesis, Inc. (2001) Summary page 1.
- K020049: Fortaflex Surgical Mesh, Organogenesis, Inc. (2002) Summary page 1.

## Most influential descendants
- K132025: Meso Bilayer Surgical Mesh (2013), 6 descendants of its own
- K163217: GORE BIO-A Tissue Reinforcement (2017), 5 descendants of its own
- K103787: Medeor Matrix (2011), 2 descendants of its own
- K232602: 3DMatrix Surgical Mesh (2024), 1 descendant of its own
- K173333: GORE ENFORM Biomaterial (2018), 1 descendant of its own

## Indications for use
The Kensey Nash ECM Surgical Patch is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair, reinforcement in plastic and reconstructive surgery, and in the urological, gynecological (excluding transvaginal repair of pelvic organ prolapse), and gastroenterological anatomy including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g., hiatal, femoral, paracolostomy, umbilical), urethral and vaginal prolapse repair (excluding transvaginal repair of pelvic organ prolapse), colon prolapse repair, rectal prolapse repair (excluding rectocele) using an abdominal approach, reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), bladder support, and sacrocolposuspension. The Kensey Nash ECM Surgical Patch is supplied sterile and intended for one time use.

Source page: https://510kreport.com/device/K094061
Methodology: https://510kreport.com/methodology