Clearance Summary
ENFit Disposable Enteral Syringe received FDA 510(k) clearance under submission number K203410, sponsored by Shantou Wealy Medical Instrument 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 2021-06-28.
- Submission: K203410
- Applicant / Sponsor: Shantou Wealy Medical Instrument Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2021-06-28
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.