Clearance Summary
AquaShield system CO2, AquaShield system-PENTAX received FDA 510(k) clearance under submission number K153362, sponsored by United States Endoscopy Group, Inc.. 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 2015-12-16.
- Submission: K153362
- Applicant / Sponsor: United States Endoscopy Group, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2015-12-16
Classification & Regulation
This clearance is catalogued under FDA product code FEQ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.