SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE— 510(k) K870028

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K870028 for SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE, Substantially Equivalent on 1987-10-26. Applicant: Radionics, Inc..

Clearance details

Applicant: Radionics, Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 1987-01-05
Decision date: 1987-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.