Cleared Traditional

CARBODISSECTING ENDOSCOPE

K020925 · Endo Surgical Devices, Inc. · Cardiovascular

Apr 2003

Decision

404d

Days

Class 2

Risk

About This 510(k) Submission

K020925 is an FDA 510(k) clearance for the CARBODISSECTING ENDOSCOPE, a Stripper, Artery, Intraluminal (Class II — Special Controls, product code DWX), submitted by Endo Surgical Devices, Inc. (Hopkonton, US). The FDA issued a Cleared decision on April 29, 2003, 404 days after receiving the submission on March 21, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number	K020925 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2002
Decision Date	April 29, 2003
Days to Decision	404 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF