ENFit enteral syringes (NUTRIFIT)— 510(k) K211661

Substantially Equivalent

Pentaferte Italia S.R.L.

FDA 510(k) clearance K211661 for ENFit enteral syringes (NUTRIFIT), Substantially Equivalent on 2022-02-28. Applicant: Pentaferte Italia S.R.L..

Clearance details

Applicant: Pentaferte Italia S.R.L.
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-01
Decision date: 2022-02-28
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.