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

Name: FDA 510(k) clearance K982101
Creator: U.S. Food and Drug Administration
Published: 2000-05-02

Substantially Equivalent

Shelhigh, Inc.

FDA 510(k) clearance K982101 for SHELHIGH NO-REACT DURA SHIELD, Substantially Equivalent on 2000-05-02. Applicant: Shelhigh, Inc.. Device class: 2.

Clearance details

Applicant: Shelhigh, Inc.
Product code: Code GXQ
Device class: Class 2
Regulation: 21 CFR 882.5910
Advisory panel: Neurology
Date received: 1998-06-15
Decision date: 2000-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millburn, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Shelhigh, Inc.

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K032893 — SHELHIGH NO-REACT BIOCUFF2003-12-19
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K991567 — SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.1999-07-14
K982810 — SHELHIGH NO-REACT VASCUPATCH1998-10-28
K981756 — SHELHIGH NO-REACT PNEUMOPLEDGETS1998-08-05

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.