CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC— 510(k) K922881

Unknown

Clarus Medical Systems, Inc.

FDA 510(k) clearance K922881 for CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC, Unknown on 1992-11-16. Applicant: Clarus Medical Systems, Inc..

Clearance details

Applicant: Clarus Medical Systems, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1992-06-16
Decision date: 1992-11-16
Decision: Unknown
Clearance type: Traditional
Location: Minneapolis, MN, 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.