EVANS SUB-Q, MODEL MC4206— 510(k) K020530

Substantially Equivalent

Evans Medical, Inc.

FDA 510(k) clearance K020530 for EVANS SUB-Q, MODEL MC4206, Substantially Equivalent on 2002-04-29. Applicant: Evans Medical, Inc..

Clearance details

Applicant: Evans Medical, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2002-02-19
Decision date: 2002-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.