Cleared Traditional

CLARUS MODEL 5197 SIGHTLITE

K971455 · Clarus Medical Systems, Inc. · Gastroenterology & Urology

May 1997

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K971455 is an FDA 510(k) clearance for the CLARUS MODEL 5197 SIGHTLITE, a Lamp, Endoscope, Incandescent (Class II — Special Controls, product code FTI), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 20, 1997, 29 days after receiving the submission on April 21, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K971455 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 1997
Decision Date	May 20, 1997
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF