CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE— 510(k) K945146

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K945146 for CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE, Substantially Equivalent on 1994-12-21. Applicant: Promex, Inc..

Clearance details

Applicant: Promex, Inc.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1994-10-20
Decision date: 1994-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.