Clearance Summary
TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* received FDA 510(k) clearance under submission number K864835, sponsored by Eisai U.S.A., 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 1987-02-11.
- Submission: K864835
- Applicant / Sponsor: Eisai U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5210
- Decision date: 1987-02-11
Classification & Regulation
This clearance is catalogued under FDA product code FCD and 21 CFR 876.5210, within the Gastroenterology, Urology review panel as a Class I device.