510(k) K123188— DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC

Substantially Equivalent

Dornoch Medical Systems, Inc.

Clearance details

Applicant: Dornoch Medical Systems, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2012-10-11
Decision date: 2013-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Riverside, MO, US

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.