Clearance Summary
END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM received FDA 510(k) clearance under submission number K943927, sponsored by American Hydro-Surgical Instruments, 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 1994-09-16.
- Submission: K943927
- Applicant / Sponsor: American Hydro-Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-09-16
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.