# K982065: Sterile Silicone External Wound Cover

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Surgical Products, Inc.
- Decided: Aug 12, 1998 after 61 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
Specialty Surgical Products Sterile Silicone Wound Covers are intended for external use in short term applications related to wound treatment by temporarily covering traumatic areas where primary closure attempts must be abandoned in favor of a staged repair.

Source page: https://510kreport.com/device/K982065
Methodology: https://510kreport.com/methodology