AMCATH URETERAL DILATORS MODELS 7100,7110,7120— 510(k) K894925

Substantially Equivalent

Intec Medical, Inc.

FDA 510(k) clearance K894925 for AMCATH URETERAL DILATORS MODELS 7100,7110,7120, Substantially Equivalent on 1989-12-13. Applicant: Intec Medical, Inc..

Clearance details

Applicant: Intec Medical, Inc.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1989-08-02
Decision date: 1989-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danielson, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZN

product code EZN

Death: 3
Injury: 127
Total: 130

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.