Clearance Summary
Padlock Clip defect closure system, Padlock Pro-Select defect closure device received FDA 510(k) clearance under submission number K192722, sponsored by STERIS Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-10-24.
- Submission: K192722
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4400
- Decision date: 2019-10-24
Classification & Regulation
This clearance is catalogued under FDA product code PKL and 21 CFR 876.4400, within the Gastroenterology, Urology review panel as a Class II device.