ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY— 510(k) K974158

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K974158 for ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY, Substantially Equivalent on 1997-12-09. Applicant: Ortho Development Corp..

Clearance details

Applicant: Ortho Development Corp.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1997-11-03
Decision date: 1997-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

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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.