COLDGEL— 510(k) K953542

Substantially Equivalent for Some Indications

Prism Technologies, Inc.

FDA 510(k) clearance K953542 for COLDGEL, Substantially Equivalent for Some Indications on 1995-10-30. Applicant: Prism Technologies, Inc..

Clearance details

Applicant: Prism Technologies, Inc.
Product code: Code IMD
Advisory panel: Physical Medicine
Date received: 1995-07-28
Decision date: 1995-10-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

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.