Clearance Summary
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 received FDA 510(k) clearance under submission number K102887, sponsored by Percutaneous Systems, 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 2011-05-16.
- Submission: K102887
- Applicant / Sponsor: Percutaneous Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4680
- Decision date: 2011-05-16
Classification & Regulation
This clearance is catalogued under FDA product code FFL and 21 CFR 876.4680, within the Gastroenterology, Urology review panel as a Class II device.