Endotics— 510(k) K190669

Substantially Equivalent

Era Endoscopy S.R.L.

FDA 510(k) clearance K190669 for Endotics, Substantially Equivalent on 2020-01-03. Applicant: Era Endoscopy S.R.L..

Clearance details

Applicant: Era Endoscopy S.R.L.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-15
Decision date: 2020-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peccioli, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.