NUTRISAFE PUR ENTERAL FEEDING TUBE— 510(k) K003311

Name: FDA 510(k) clearance K003311
Creator: U.S. Food and Drug Administration
Published: 2002-01-11

Substantially Equivalent

Vygon Corp.

FDA 510(k) clearance K003311 for NUTRISAFE PUR ENTERAL FEEDING TUBE, Substantially Equivalent on 2002-01-11. Applicant: Vygon Corp.. Device class: 2.

Clearance details

Applicant: Vygon Corp.
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2000-10-23
Decision date: 2002-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPD

view all

K243361 — Nutrifit2024-12-19
K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)2019-01-18
K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE2013-10-23
K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE2013-03-06
K121105 — NUTRISAFE 2 FEEDING TUBE2012-12-18

More clearances from Vygon Corp.

view all

K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX2011-10-13
K073493 — HEPATOSTAT SET2008-05-06
K070705 — MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.0392007-11-30
K061796 — HEPATOSTAT SET, MODEL 760X2006-11-02
K061250 — MULTICATH EXPERT2006-09-29

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.