K.E.P. CONNECTOR AND CLIP— 510(k) K042900

Substantially Equivalent

K.E.P., LLC

FDA 510(k) clearance K042900 for K.E.P. CONNECTOR AND CLIP, Substantially Equivalent on 2004-11-05. Applicant: K.E.P., LLC.

Clearance details

Applicant: K.E.P., LLC
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 2004-10-19
Decision date: 2004-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.