Disposable Enteral Feeding Syringe with Enfit Connector— 510(k) K193657

Substantially Equivalent

Shinva Ande Healthcare Apparatus Co., Ltd.

FDA 510(k) clearance K193657 for Disposable Enteral Feeding Syringe with Enfit Connector, Substantially Equivalent on 2020-09-12. Applicant: Shinva Ande Healthcare Apparatus Co., Ltd..

Clearance details

Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2019-12-30
Decision date: 2020-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, 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.