FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR— 510(k) K932809

Substantially Equivalent

Excalibur Engineering Care of Rms, Inc.

FDA 510(k) clearance K932809 for FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR, Substantially Equivalent on 1994-03-17. Applicant: Excalibur Engineering Care of Rms, Inc..

Clearance details

Applicant: Excalibur Engineering Care of Rms, Inc.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1993-06-09
Decision date: 1994-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Florida, FL, US

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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.