VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)— 510(k) K180236

Name: FDA 510(k) clearance K180236
Creator: U.S. Food and Drug Administration
Published: 2019-01-18

Substantially Equivalent

Vr Medical Technology Co., Ltd.

FDA 510(k) clearance K180236 for VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES), Substantially Equivalent on 2019-01-18. Applicant: Vr Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Vr Medical Technology Co., Ltd.
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2018-01-29
Decision date: 2019-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhouzhuang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPD

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K243361 — Nutrifit2024-12-19
K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE2013-10-23
K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE2013-03-06
K121105 — NUTRISAFE 2 FEEDING TUBE2012-12-18
K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX2011-10-13

Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.