Clearance Summary
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA received FDA 510(k) clearance under submission number K964561, sponsored by Bioenterics Corp.. 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 1997-02-11.
- Submission: K964561
- Applicant / Sponsor: Bioenterics Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4530
- Decision date: 1997-02-11
Classification & Regulation
This clearance is catalogued under FDA product code FDG and 21 CFR 876.4530, within the Gastroenterology, Urology review panel as a Class I device.