Clearance Summary
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET received FDA 510(k) clearance under submission number K852287, sponsored by Cook Ob/Gyn. 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 1985-08-08.
- Submission: K852287
- Applicant / Sponsor: Cook Ob/Gyn
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 1985-08-08
Classification & Regulation
This clearance is catalogued under FDA product code KOB and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class II device.