Cleared Traditional

K093603 - STORM-BASE 2.0 (FDA 510(k) Clearance)

K093603 · KARL STORZ Endoscopy-America, Inc. · Radiology device

Mar 2010

Decision

118d

Days

Class 2

Risk

K093603 is an FDA 510(k) clearance for the STORM-BASE 2.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on March 18, 2010, 118 days after receiving the submission on November 20, 2009.

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

Submission Details

510(k) Number	K093603 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 20, 2009
Decision Date	March 18, 2010
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF