Clearance Summary
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W received FDA 510(k) clearance under submission number K013144, sponsored by C.R. Bard, 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 2001-10-19.
- Submission: K013144
- Applicant / Sponsor: C.R. Bard, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2001-10-19
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.