Clearance Summary
EASY LOOP, MODEL EZL-01 received FDA 510(k) clearance under submission number K040110, sponsored by Tools For Surgery, LLC. 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 2004-03-24.
- Submission: K040110
- Applicant / Sponsor: Tools For Surgery, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4270
- Decision date: 2004-03-24
Classification & Regulation
This clearance is catalogued under FDA product code EZP and 21 CFR 876.4270, within the Gastroenterology, Urology review panel as a Class II device.