Clearance Summary
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM received FDA 510(k) clearance under submission number K031786, sponsored by Vision-Sciences, 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 2003-08-05.
- Submission: K031786
- Applicant / Sponsor: Vision-Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4710
- Decision date: 2003-08-05
Classification & Regulation
This clearance is catalogued under FDA product code EOX and 21 CFR 874.4710, within the Ear, Nose, Throat review panel as a Class II device.