SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L

FDA 510(k) K091656 · Organ Recovery Systems, Inc.

Substantially Equivalent

510(k) numberK091656

Submission

Device name
SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L
Applicant
Organ Recovery Systems, Inc.
Des Plaines, IL, US
Received
June 9, 2009
Decision date
March 11, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KDL – Set, Perfusion, Kidney, Disposable
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5880
Specialty
Gastroenterology, Urology

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More from Dr. Franz Kohler Chemie GmbH

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Questions and answers

When was SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L cleared by the FDA?

SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L (K091656) received a 510(k) decision of Substantially Equivalent on March 11, 2010, 275 days after the submission was received.

What is the product code of K091656?

The FDA product code is KDL – Set, Perfusion, Kidney, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5880.