Clearance Summary
CORE AND COIL ASSEMBLY GUIDEWIRE received FDA 510(k) clearance under submission number K970994, sponsored by Lake Region Mfg., Inc.. 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 1997-03-25.
- Submission: K970994
- Applicant / Sponsor: Lake Region Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5130
- Decision date: 1997-03-25
Classification & Regulation
This clearance is catalogued under FDA product code EZB and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class I device.