NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX— 510(k) K100163

Substantially Equivalent

Vygon Corp.

FDA 510(k) clearance K100163 for NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX, Substantially Equivalent on 2011-10-13. 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: 2010-01-20
Decision date: 2011-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montgomeryville, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vygon Corp.

K073493 — HEPATOSTAT SET2008-05-06
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K061796 — HEPATOSTAT SET, MODEL 760X2006-11-02
K061250 — MULTICATH EXPERT2006-09-29
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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.