ENConnect 40 mm Screw Cap to ENPlus Adapter— 510(k) K190327

Substantially Equivalent

Cedic S.R.L.

FDA 510(k) clearance K190327 for ENConnect 40 mm Screw Cap to ENPlus Adapter, Substantially Equivalent on 2019-04-09. Applicant: Cedic S.R.L..

Clearance details

Applicant: Cedic S.R.L.
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2019-02-13
Decision date: 2019-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peschiera Borromeo, IT

Download summary PDF View on FDA.gov ↗

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.