MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.— 510(k) K880216

Substantially Equivalent

Directed Energy, Inc.

FDA 510(k) clearance K880216 for MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP., Substantially Equivalent on 1988-03-04. Applicant: Directed Energy, Inc..

Clearance details

Applicant: Directed Energy, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1988-01-20
Decision date: 1988-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.