Clearance Summary
SnapLoc Wire Lock received FDA 510(k) clearance under submission number K213483, sponsored by Wilson Cook Medical. 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 2022-04-26.
- Submission: K213483
- Applicant / Sponsor: Wilson Cook Medical
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2022-04-26
Classification & Regulation
This clearance is catalogued under FDA product code ODC and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.