Clearance Summary
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE received FDA 510(k) clearance under submission number K984157, sponsored by Wilson-Cook Medical, 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 1998-12-08.
- Submission: K984157
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 1998-12-08
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.