REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200— 510(k) K110941

Substantially Equivalent

Allmed Systems, Inc.

FDA 510(k) clearance K110941 for REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200, Substantially Equivalent on 2013-02-19. Applicant: Allmed Systems, Inc..

Clearance details

Applicant: Allmed Systems, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2011-04-04
Decision date: 2013-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, 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.