NETHERY EXTREMITY FREEZING UNIT— 510(k) K844246

Substantially Equivalent

Howard J. Nethery & Assoc.

FDA 510(k) clearance K844246 for NETHERY EXTREMITY FREEZING UNIT, Substantially Equivalent on 1985-02-28. Applicant: Howard J. Nethery & Assoc..

Clearance details

Applicant: Howard J. Nethery & Assoc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 1984-11-01
Decision date: 1985-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

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Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.