Clearance Summary
Plenity received FDA 510(k) clearance under submission number DEN180060, sponsored by Gelesis, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-04-12.
- Submission: DEN180060
- Applicant / Sponsor: Gelesis, Inc.
- Clearance pathway: Direct
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5982
- Decision date: 2019-04-12
Classification & Regulation
This clearance is catalogued under FDA product code QFQ and 21 CFR 876.5982, within the Gastroenterology, Urology review panel as a Class II device.