THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751— 510(k) K082241

Substantially Equivalent

Dale Medical Products, Inc.

FDA 510(k) clearance K082241 for THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751, Substantially Equivalent on 2008-10-30. Applicant: Dale Medical Products, Inc..

Clearance details

Applicant: Dale Medical Products, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2008-08-07
Decision date: 2008-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.