SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600— 510(k) K993265

Substantially Equivalent

Soring GmbH Medizintechnik

FDA 510(k) clearance K993265 for SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600, Substantially Equivalent on 1999-10-22. Applicant: Soring GmbH Medizintechnik.

Clearance details

Applicant: Soring GmbH Medizintechnik
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1999-09-29
Decision date: 1999-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.