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

Name: FDA 510(k) clearance K993265
Creator: U.S. Food and Drug Administration
Published: 1999-10-22

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. Device class: 2.

Clearance details

Applicant: Soring GmbH Medizintechnik
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
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

Download summary PDF View on FDA.gov ↗

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K024059 — MBC SERIES2003-01-08
K012753 — SORING GMBH SONOCA 180/1902001-11-13

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.