Cleared Traditional

K011591 - ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE (FDA 510(k) Clearance)

K011591 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device

Jul 2002

Decision

421d

Days

Class 2

Risk

K011591 is an FDA 510(k) clearance for the ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on July 19, 2002, 421 days after receiving the submission on May 24, 2001.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number	K011591 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 24, 2001
Decision Date	July 19, 2002
Days to Decision	421 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF