Pentaflush— 510(k) K214080

Substantially Equivalent

Pentaferte Italia S.R.L.

FDA 510(k) clearance K214080 for Pentaflush, Substantially Equivalent on 2022-07-20. Applicant: Pentaferte Italia S.R.L..

Clearance details

Applicant: Pentaferte Italia S.R.L.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2021-12-27
Decision date: 2022-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campli Teramo, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code NGT

product code NGT

Death: 12
Malfunction: 2,008
Other: 4
Total: 2,024

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.