Clearance Summary
TAYLOR CATHETER HOLDER received FDA 510(k) clearance under submission number K780411, sponsored by Taylor Catheter Holder Mfg.. 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 1978-04-13.
- Submission: K780411
- Applicant / Sponsor: Taylor Catheter Holder Mfg.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1978-04-13
Classification & Regulation
This clearance is catalogued under FDA product code EZD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.