COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON— 510(k) K061937

Substantially Equivalent

Cook Endoscopy

FDA 510(k) clearance K061937 for COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON, Substantially Equivalent on 2006-12-01. Applicant: Cook Endoscopy.

Clearance details

Applicant: Cook Endoscopy
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 2006-07-10
Decision date: 2006-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.