510(k) K191067— Arc Endocuff Glide AEG110 & AEG120

Substantially Equivalent

Boddingtons Plastics, Ltd.

Clearance details

Applicant: Boddingtons Plastics, Ltd.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-22
Decision date: 2019-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Tonbridge, GB

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.