Clearance Summary
URINARY DRAINAGE BAG CADDY received FDA 510(k) clearance under submission number K931727, sponsored by Neotech Products, 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 1993-07-23.
- Submission: K931727
- Applicant / Sponsor: Neotech Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1993-07-23
Classification & Regulation
This clearance is catalogued under FDA product code FAQ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.