Clearance Summary
Disposable Enteral Feeding Syringe with Enfit Connector received FDA 510(k) clearance under submission number K193657, sponsored by Shinva Ande Healthcare Apparatus 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 2020-09-12.
- Submission: K193657
- Applicant / Sponsor: Shinva Ande Healthcare Apparatus Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2020-09-12
Classification & Regulation
This clearance is catalogued under FDA product code PNR and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.