Cleared Traditional

BEL-GEN COLD STORAGE SOLUTION

K121618 · Waters Medical Systems, LLC · Gastroenterology & Urology

Jun 2013

Decision

378d

Days

Class 2

Risk

About This 510(k) Submission

K121618 is an FDA 510(k) clearance for the BEL-GEN COLD STORAGE SOLUTION, a Set, Perfusion, Kidney, Disposable (Class II — Special Controls, product code KDL), submitted by Waters Medical Systems, LLC (Rochester, US). The FDA issued a Cleared decision on June 14, 2013, 378 days after receiving the submission on June 1, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.

Submission Details

510(k) Number	K121618 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2012
Decision Date	June 14, 2013
Days to Decision	378 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF