Clearance Summary
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR received FDA 510(k) clearance under submission number K021166, sponsored by Acmi-Circon Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2002-05-09.
- Submission: K021166
- Applicant / Sponsor: Acmi-Circon Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2002-05-09
Classification & Regulation
This clearance is catalogued under FDA product code FDC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.