Clearance Summary
ENDOSCOPIC ACCESSORY received FDA 510(k) clearance under submission number K945191, sponsored by Un-I-Med, 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 1995-05-03.
- Submission: K945191
- Applicant / Sponsor: Un-I-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1995-05-03
Classification & Regulation
This clearance is catalogued under FDA product code FAS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.