Clearance Summary
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C received FDA 510(k) clearance under submission number K021632, sponsored by Uresil, L.P.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2002-06-13.
- Submission: K021632
- Applicant / Sponsor: Uresil, L.P.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 2002-06-13
Classification & Regulation
This clearance is catalogued under FDA product code GBO and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.