Clearance Summary
GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER received FDA 510(k) clearance under submission number K881213, sponsored by Geneva Laboratories, 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 1988-07-28.
- Submission: K881213
- Applicant / Sponsor: Geneva Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1988-07-28
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.