510(k) K133786— DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID

Substantially Equivalent

Dornoch Medical Systems, Inc.

Clearance details

Applicant: Dornoch Medical Systems, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2013-12-12
Decision date: 2014-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
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.