Clearance Summary
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 received FDA 510(k) clearance under submission number K100899, sponsored by Keymed (Medical & Industrial Equipment), Ltd.. 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 2010-09-13.
- Submission: K100899
- Applicant / Sponsor: Keymed (Medical & Industrial Equipment), Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-09-13
Classification & Regulation
This clearance is catalogued under FDA product code FEQ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.