Clearance Summary
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector received FDA 510(k) clearance under submission number K163586, sponsored by Trovrx, Inc. Dba Trovita Health Science. 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 2017-03-17.
- Submission: K163586
- Applicant / Sponsor: Trovrx, Inc. Dba Trovita Health Science
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2017-03-17
Classification & Regulation
This clearance is catalogued under FDA product code PIF and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.