Clearance Summary
PRE-FILLED CATHETER INFLATION SYRINGE received FDA 510(k) clearance under submission number K090121, sponsored by Avail Medical Products, Inc.. 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 2009-04-15.
- Submission: K090121
- Applicant / Sponsor: Avail Medical Products, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2009-04-15
Classification & Regulation
This clearance is catalogued under FDA product code KNY and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.