Clearance Summary
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 received FDA 510(k) clearance under submission number K023358, sponsored by Acmi Corporation. 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 2003-01-03.
- Submission: K023358
- Applicant / Sponsor: Acmi Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2003-01-03
Classification & Regulation
This clearance is catalogued under FDA product code FGB and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.