Nutrifit— 510(k) K243361

Name: FDA 510(k) clearance K243361
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Substantially Equivalent

Vygon USA

FDA 510(k) clearance K243361 for Nutrifit, Substantially Equivalent on 2024-12-19. Applicant: Vygon USA. Device class: 2.

Clearance details

Applicant: Vygon USA
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2024-10-29
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale Montgomery, PA, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Vygon USA

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K212370 — Leaderflex Mini and Leaderflex Nano2022-08-29
K181208 — Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter2018-11-02
K172899 — Vygon PICCs2018-02-26

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.