510(k) K211025
K211025 is an FDA 510(k) premarket notification submitted by Ningbo Tianyi Medical Appliance Co., Ltd. for the device "Oral/Enteral Syringe with ENFit connector". The FDA issued a decision of Substantially Equivalent on June 30, 2021. The device falls under product code PNR (Enteral Syringes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Ningbo Tianyi Medical Appliance Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2021
- Date Received
- April 6, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enteral Syringes With Enteral Specific Connectors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.