ABI Instrument, Creo Electrosurgical System— 510(k) K200298

Substantially Equivalent

Creo Medical, Ltd.

FDA 510(k) clearance K200298 for ABI Instrument, Creo Electrosurgical System, Substantially Equivalent on 2021-01-05. Applicant: Creo Medical, Ltd..

Clearance details

Applicant: Creo Medical, Ltd.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2020-02-06
Decision date: 2021-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chepstow, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.