510(k) K984157— MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE

Substantially Equivalent

Wilson-Cook Medical, Inc.

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 1998-11-19
Decision date: 1998-12-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Winston-Salem, NC, US

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.