Clearance Summary
ENDOSHEATH received FDA 510(k) clearance under submission number K990354, 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 1999-03-31.
- Submission: K990354
- Applicant / Sponsor: Vision-Sciences, Inc.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 1999-03-31
Classification & Regulation
This clearance is catalogued under FDA product code EOB and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.