J-FX BIPOLAR HEAD— 510(k) K980801

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K980801 for J-FX BIPOLAR HEAD, Substantially Equivalent on 1998-05-29. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1998-03-02
Decision date: 1998-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.