Clearance Summary
Accordion Piccolo Stone Management Device received FDA 510(k) clearance under submission number K172299, sponsored by Ths International, Inc. D/B/A Accordion Medical. 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 2017-09-19.
- Submission: K172299
- Applicant / Sponsor: Ths International, Inc. D/B/A Accordion Medical
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4680
- Decision date: 2017-09-19
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.