BALLOON DILATION CATHETER— 510(k) K896448

Substantially Equivalent

Cook Ob/Gyn

FDA 510(k) clearance K896448 for BALLOON DILATION CATHETER, Substantially Equivalent on 1990-03-07. Applicant: Cook Ob/Gyn.

Clearance details

Applicant: Cook Ob/Gyn
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-09
Decision date: 1990-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, 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.