Tri-Ex Extraction Balloon with Multiple Sizing— 510(k) K193344

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K193344 for Tri-Ex Extraction Balloon with Multiple Sizing, Substantially Equivalent on 2019-12-13. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code GCA
Advisory panel: Gastroenterology, Urology
Date received: 2019-12-03
Decision date: 2019-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.