RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE— 510(k) K971511

Substantially Equivalent

Radionics, Inc.

FDA 510(k) clearance K971511 for RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE, Substantially Equivalent on 1997-07-24. Applicant: Radionics, Inc..

Clearance details

Applicant: Radionics, Inc.
Product code: Code JXG
Advisory panel: Neurology
Date received: 1997-04-28
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.