Oral/Enteral Syringe with ENFit connector— 510(k) K211025

Substantially Equivalent

Ningbo Tianyi Medical Appliance Co., Ltd.

FDA 510(k) clearance K211025 for Oral/Enteral Syringe with ENFit connector, Substantially Equivalent on 2021-06-30. Applicant: Ningbo Tianyi Medical Appliance Co., Ltd..

Clearance details

Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2021-04-06
Decision date: 2021-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.