POLARIS 100/200— 510(k) K123776

Name: FDA 510(k) clearance K123776
Creator: U.S. Food and Drug Administration
Published: 2013-03-08

Substantially Equivalent

Drager Medical GmbH

FDA 510(k) clearance K123776 for POLARIS 100/200, Substantially Equivalent on 2013-03-08. Applicant: Drager Medical GmbH. Device class: 2.

Clearance details

Applicant: Drager Medical GmbH
Product code: Code FTD
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2012-12-10
Decision date: 2013-03-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.