Arc Enterocuff— 510(k) K191330

Substantially Equivalent

Boddingtons Plastics, Ltd.

FDA 510(k) clearance K191330 for Arc Enterocuff, Substantially Equivalent on 2020-01-31. Applicant: Boddingtons Plastics, Ltd..

Clearance details

Applicant: Boddingtons Plastics, Ltd.
Product code: Code FDA
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-16
Decision date: 2020-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonbridge, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.