# K101851: Ventralight ST Mesh

- Pathway: 510(k) (Special)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: Jul 15, 2010 after 14 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971745 (1997). 8 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040868: Sepramesh IP Bioresorbable Barrier - Permanent Mesh, Genzyme Corp. (2004) Summary page 1.
- K053066: Sepramesh IP Bioresorbable Coating/Permanent Mesh, Genzyme Corporation (2005) Summary page 1.
- K063739: Sepramesh, Model 5959-1214, Genzyme Corporation (2007) Summary page 1.

## Most influential descendants
- K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (2011), 5 descendants of its own
- K143380: Phasix ST Mesh (2015), 4 descendants of its own
- K122436: Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System (2012), 4 descendants of its own
- K130968: Ventralight ST Mesh with Echo PS Positioning System (2013), 3 descendants of its own
- K143743: ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH (2015), 2 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-2413-2012: Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh
- Sep 4, 2012 · Class II · Z-2412-2012: Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product

## Indications for use
The Ventralight ST Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Source page: https://510kreport.com/device/K101851
Methodology: https://510kreport.com/methodology