SHELHIGH BIORING— 510(k) K023940

Substantially Equivalent

Shelhigh, Inc.

FDA 510(k) clearance K023940 for SHELHIGH BIORING, Substantially Equivalent on 2003-06-04. Applicant: Shelhigh, Inc..

Clearance details

Applicant: Shelhigh, Inc.
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2002-11-26
Decision date: 2003-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

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.