TRANSPOSAL ULTRA SYSTEMS— 510(k) K081047

Substantially Equivalent

Dornoch Medical Systems, Inc.

FDA 510(k) clearance K081047 for TRANSPOSAL ULTRA SYSTEMS, Substantially Equivalent on 2008-04-29. Applicant: Dornoch Medical Systems, Inc..

Clearance details

Applicant: Dornoch Medical Systems, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2008-04-14
Decision date: 2008-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, MO, US

Download summary PDF View on FDA.gov ↗

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.