ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM— 510(k) K112945

Substantially Equivalent

Inrad, Inc.

FDA 510(k) clearance K112945 for ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM, Substantially Equivalent on 2011-11-03. Applicant: Inrad, Inc..

Clearance details

Applicant: Inrad, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2011-10-04
Decision date: 2011-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.