# K971472: Sil-Tec Nonreinforced Sheeting, Reinforced Sheeting, Radiopaque Sheeting, Reinforced Radiopaque Sheeting, Extra Firm Gra

- Pathway: 510(k) (Traditional)
- Applicant: Technical Products, Inc.
- Decided: Jul 1, 1997 after 69 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
Sil-Tec Medical Grade Silicone Sheeting is suitable for external use or short-term implantation (30 days or less). Sil-Tec sheeting is intended for modification with a scalpel or scissors, by the surgeon or medical practitioner, for his/her own custom patient-specific applications. Patient selection and suitability is up to the surgeon/medical practitioner user. The surgeon/medical practitioner user must rely on his or her own best medical judgment and training as to the use of this device. The following are some indications where silicone sheeting has been successfully employed: Surgical repairs; anchoring device for hemodialysis shunts; temporary covering for a prenatally ruptured omphalocele during staged repair; surgical repair of urethral strictures; protective sheathing to help facilitate neural regeneration and tendon healing; surgical repair of fractured orbital floors; to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus (Warning Note: Not for permanent use in the presence of degenerative bone changes, chronic bruxism, or temporomandibular joint applications); other surgical procedures; and as insulating material for tissue accumulation. It is the surgeon/medical practitioner user's responsibility to thoroughly test any products made in part or otherwise incorporating Sil-Tec medical grade sheeting to determine the acceptability of the product's performance in a specific application.

Source page: https://510kreport.com/device/K971472
Methodology: https://510kreport.com/methodology