CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,— 510(k) K103128

Substantially Equivalent

Cadwell Lab, Inc.

FDA 510(k) clearance K103128 for CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,, Substantially Equivalent on 2011-02-23. Applicant: Cadwell Lab, Inc..

Clearance details

Applicant: Cadwell Lab, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2010-10-25
Decision date: 2011-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennewick, WA, US

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Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.