ARC ENDOCUFF— 510(k) K122565

Name: FDA 510(k) clearance K122565
Creator: U.S. Food and Drug Administration
Published: 2012-09-04

Substantially Equivalent

Boddingtons Plastics, Ltd.

FDA 510(k) clearance K122565 for ARC ENDOCUFF, Substantially Equivalent on 2012-09-04. Applicant: Boddingtons Plastics, Ltd.. Device class: 2.

Clearance details

Applicant: Boddingtons Plastics, Ltd.
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2012-08-22
Decision date: 2012-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonbridge, Kent, GB

Download summary PDF View on FDA.gov ↗

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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.