Clearance Summary
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE received FDA 510(k) clearance under submission number K071903, sponsored by Vision-Sciences, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2007-08-02.
- Submission: K071903
- Applicant / Sponsor: Vision-Sciences, Inc.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4710
- Decision date: 2007-08-02
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.