ECHOTIP ULTRA ULTRASOUND NEEDLE— 510(k) K083330

Name: FDA 510(k) clearance K083330
Creator: U.S. Food and Drug Administration
Published: 2009-02-06

Substantially Equivalent

Cook Endoscopy

FDA 510(k) clearance K083330 for ECHOTIP ULTRA ULTRASOUND NEEDLE, Substantially Equivalent on 2009-02-06. Applicant: Cook Endoscopy. Device class: 2.

Clearance details

Applicant: Cook Endoscopy
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2008-11-12
Decision date: 2009-02-06
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 FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.