COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON— 510(k) K061937

Name: FDA 510(k) clearance K061937
Creator: U.S. Food and Drug Administration
Published: 2006-12-01

Substantially Equivalent

Cook Endoscopy

FDA 510(k) clearance K061937 for COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON, Substantially Equivalent on 2006-12-01. Applicant: Cook Endoscopy. Device class: 2.

Clearance details

Applicant: Cook Endoscopy
Product code: Code KNQ
Device class: Class 2
Regulation: 21 CFR 876.5365
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 ↗

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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.