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

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K984157 for MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE, Substantially Equivalent on 1998-12-08. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.

Clearance details

Applicant
Wilson-Cook Medical, Inc.
Product code
Code EOQ
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Winston-Salem, NC, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

Source: openFDA MAUDE database, through . 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.