Clearance Summary
Creo Electrosurgical System with HS1 Hemostasis Accessory received FDA 510(k) clearance under submission number K192905, sponsored by Creo Medical, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-03-19.
- Submission: K192905
- Applicant / Sponsor: Creo Medical, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2020-03-19
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.