SHELHIGH NO-REACT DURA SHIELD— 510(k) K982101

Substantially Equivalent

Shelhigh, Inc.

FDA 510(k) clearance K982101 for SHELHIGH NO-REACT DURA SHIELD, Substantially Equivalent on 2000-05-02. Applicant: Shelhigh, Inc..

Clearance details

Applicant: Shelhigh, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 1998-06-15
Decision date: 2000-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millburn, NJ, US

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Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.