U Deliver Bolink ENFit Enteral Feeding Sets— 510(k) K190310

Name: FDA 510(k) clearance K190310
Creator: U.S. Food and Drug Administration
Published: 2019-05-31

Substantially Equivalent

U Deliver Medical, LLC

FDA 510(k) clearance K190310 for U Deliver Bolink ENFit Enteral Feeding Sets, Substantially Equivalent on 2019-05-31. Applicant: U Deliver Medical, LLC. Device class: 2.

Clearance details

Applicant: U Deliver Medical, LLC
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2019-02-12
Decision date: 2019-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.