Clearance Summary
Balloon BS-3 received FDA 510(k) clearance under submission number K213195, sponsored by Fujifilm Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-10-29.
- Submission: K213195
- Applicant / Sponsor: Fujifilm Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2021-10-29
Classification & Regulation
This clearance is catalogued under FDA product code FDA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.