# K982101: Shelhigh NO-React Dura Shield

- Pathway: 510(k) (Traditional)
- Applicant: Shelhigh, Inc.
- Decided: May 2, 2000 after 687 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- 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. The FDA summary names its predicate without a number.
- (no number) Dura Guard®: named in the summary without a submission number
- (no number) Shelhigh No-React® Pericardial Patch: named in the summary without a submission number

## Indications for use
The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.

Source page: https://510kreport.com/device/K982101
Methodology: https://510kreport.com/methodology