# K973082: Ventral Wall Defect Reduction Silo

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Surgical Products, Inc.
- Decided: Nov 4, 1997 after 78 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Specialty Surgical Products Ventral Wall Defect Reduction Silo is indicated for use in the treatment of large ventral wall defects, including gastroschisis and ompalocele, where primary closure attempts must be abandoned in favor of a staged repair.

Source page: https://510kreport.com/device/K973082
Methodology: https://510kreport.com/methodology