ECHOTIP(R) ULTRA FIDUCIAL NEEDLE— 510(k) K111895

Substantially Equivalent

Wilson-Cook Medical Inc./Cook Endoscopy

FDA 510(k) clearance K111895 for ECHOTIP(R) ULTRA FIDUCIAL NEEDLE, Substantially Equivalent on 2012-04-27. Applicant: Wilson-Cook Medical Inc./Cook Endoscopy.

Clearance details

Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2011-07-05
Decision date: 2012-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.