TECHMEDICA STANDARD BIPOLAR SYSTEM— 510(k) K925420

Substantially Equivalent

Techmedica, Inc.

FDA 510(k) clearance K925420 for TECHMEDICA STANDARD BIPOLAR SYSTEM, Substantially Equivalent on 1993-09-28. Applicant: Techmedica, Inc..

Clearance details

Applicant: Techmedica, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1992-10-27
Decision date: 1993-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, 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.