Clearance Summary
ORAL/ENTERAL SYRINGES received FDA 510(k) clearance under submission number K100099, sponsored by Philips Children'S Medical Ventures. 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 2010-06-14.
- Submission: K100099
- Applicant / Sponsor: Philips Children'S Medical Ventures
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2010-06-14
Classification & Regulation
This clearance is catalogued under FDA product code FPD and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.