URETERAL BULB DILATORS— 510(k) K873178

Substantially Equivalent

Penn Medical Devices, Inc.

FDA 510(k) clearance K873178 for URETERAL BULB DILATORS, Substantially Equivalent on 1987-09-30. Applicant: Penn Medical Devices, Inc..

Clearance details

Applicant: Penn Medical Devices, Inc.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1987-08-12
Decision date: 1987-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basking Ridge, NJ, 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.