PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES— 510(k) K011206

Substantially Equivalent

Parallax Medical, Inc.

FDA 510(k) clearance K011206 for PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES, Substantially Equivalent on 2001-07-18. Applicant: Parallax Medical, Inc..

Clearance details

Applicant: Parallax Medical, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-19
Decision date: 2001-07-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Scotts Valley, CA, 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.