510(k) K203613— ENFit Reusable Enteral Syringe

Substantially Equivalent

Shantou Wealy Medical Instrument Co.,Ltd

Clearance details

Applicant: Shantou Wealy Medical Instrument Co.,Ltd
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2020-12-10
Decision date: 2021-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shantou, CN

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.