Clearance Summary
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM received FDA 510(k) clearance under submission number K021344, 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 2002-05-24.
- Submission: K021344
- Applicant / Sponsor: Vision-Sciences, Inc.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2002-05-24
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.