Clearance Summary
C2 CryoBalloon EndoGrip received FDA 510(k) clearance under submission number K193036, sponsored by Pentax Medical, A Division of Pentax of America, 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 2019-11-22.
- Submission: K193036
- Applicant / Sponsor: Pentax Medical, A Division of Pentax of America, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2019-11-22
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.