# K973166: Dow Corning Silastic Elastomer Q7-4750

- Pathway: 510(k) (Traditional)
- Applicant: Technical Products, Inc.
- Decided: Nov 21, 1997 after 88 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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 rod is a soft, translucent silicon elastomer rod intended for reconstruction and surgical repair procedures. The rod is made in two grades of material: 1. The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days. 2. The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days. Some uses have been: 1. As temporary stents for the formation of new tendon sheaths 2. Other surgical repair procedures demanding a highly inert and flexible rod shaped material

Source page: https://510kreport.com/device/K973166
Methodology: https://510kreport.com/methodology