Clearance Summary
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) received FDA 510(k) clearance under submission number K190829, sponsored by Wilson-Cook Medical Inc./Cook Endoscopy. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-12-19.
- Submission: K190829
- Applicant / Sponsor: Wilson-Cook Medical Inc./Cook Endoscopy
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-12-19
Classification & Regulation
This clearance is catalogued under FDA product code FBK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.