Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory— 510(k) K171983

Substantially Equivalent

Creo Medical, Ltd.

FDA 510(k) clearance K171983 for Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory, Substantially Equivalent on 2017-08-17. Applicant: Creo Medical, Ltd..

Clearance details

Applicant: Creo Medical, Ltd.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-30
Decision date: 2017-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chepstow, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.