Clearance Summary
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH received FDA 510(k) clearance under submission number K970107, sponsored by Urohealth Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1997-11-18.
- Submission: K970107
- Applicant / Sponsor: Urohealth Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 1997-11-18
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.