Clearance Summary
INTROCULAR FLUID INJECTOR received FDA 510(k) clearance under submission number K881707, sponsored by B&B Medical Assoc., Inc.. 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 1988-10-21.
- Submission: K881707
- Applicant / Sponsor: B&B Medical Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1988-10-21
Classification & Regulation
This clearance is catalogued under FDA product code FIH and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.