Clearance Summary
Vacutore Air/Water Bottle Tubing received FDA 510(k) clearance under submission number K191366, sponsored by Smartdata Suzhou Co., Ltd.. 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 2019-09-06.
- Submission: K191366
- Applicant / Sponsor: Smartdata Suzhou Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-09-06
Classification & Regulation
This clearance is catalogued under FDA product code OCX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.