Clearance Summary
ENEMA KIT received FDA 510(k) clearance under submission number K913620, sponsored by York County Blind Center. 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 1991-11-01.
- Submission: K913620
- Applicant / Sponsor: York County Blind Center
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5210
- Decision date: 1991-11-01
Classification & Regulation
This clearance is catalogued under FDA product code FCE and 21 CFR 876.5210, within the Gastroenterology, Urology review panel as a Class I device.