Clearance Summary
MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS received FDA 510(k) clearance under submission number K881478, 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 1988-09-14.
- Submission: K881478
- Applicant / Sponsor: Keymed (Medical & Industrial Equipment), Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5365
- Decision date: 1988-09-14
Classification & Regulation
This clearance is catalogued under FDA product code KNQ and 21 CFR 876.5365, within the Gastroenterology, Urology review panel as a Class II device.