Clearance Summary
FiXcision received FDA 510(k) clearance under submission number K182664, sponsored by Agency For Medical Innovations GmbH. 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 2018-12-07.
- Submission: K182664
- Applicant / Sponsor: Agency For Medical Innovations GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 2018-12-07
Classification & Regulation
This clearance is catalogued under FDA product code KOA and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.