Cleared Traditional

K024159 - STRYKERWARE SYSTEM (FDA 510(k) Clearance)

K024159 · Stryker Endoscopy · Radiology device

Mar 2003

Decision

83d

Days

Class 2

Risk

K024159 is an FDA 510(k) clearance for the STRYKERWARE SYSTEM. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on March 10, 2003, 83 days after receiving the submission on December 17, 2002.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K024159 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 2002
Decision Date	March 10, 2003
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF