ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT— 510(k) K161141

Substantially Equivalent

Pentaferte Italia S.R.L.

FDA 510(k) clearance K161141 for ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT, Substantially Equivalent on 2017-03-22. Applicant: Pentaferte Italia S.R.L..

Clearance details

Applicant: Pentaferte Italia S.R.L.
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2016-04-22
Decision date: 2017-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campli, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

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.