# K130968: Ventralight ST Mesh with Echo PS Positioning System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 1, 2013 after 23 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K971745 (1997). 35 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122436: Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System, C.R. Bard, Inc. (2012) Summary page 1.

## Most influential descendants
- K143743: ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH (2015), 2 descendants of its own
- K170294: VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse,  VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval (2017), 1 descendant of its own
- K182008: Phasix ST Mesh with Echo 2 Positioning System (2018), 0 descendants of its own

## Recalls of this device
- Apr 25, 2023 · Class II · Z-2241-2023: Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, e
- Apr 25, 2023 · Class II · Z-2244-2023: Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, e
- Apr 25, 2023 · Class II · Z-2243-2023: Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, e
- Apr 25, 2023 · Class II · Z-2242-2023: Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, e

## Indications for use
Ventralight ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo PS Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.

Source page: https://510kreport.com/device/K130968
Methodology: https://510kreport.com/methodology