Clearance Summary
AFS Medical Sterile Single-Use Access Port System received FDA 510(k) clearance under submission number K202688, sponsored by Afs Medical Co. , 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 2021-10-14.
- Submission: K202688
- Applicant / Sponsor: Afs Medical Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2021-10-14
Classification & Regulation
This clearance is catalogued under FDA product code OTJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.