SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L— 510(k) K091656

Name: FDA 510(k) clearance K091656
Creator: U.S. Food and Drug Administration
Published: 2010-03-11

Substantially Equivalent

Organ Recovery Systems, Inc.

FDA 510(k) clearance K091656 for SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L, Substantially Equivalent on 2010-03-11. Applicant: Organ Recovery Systems, Inc.. Device class: 2.

Clearance details

Applicant: Organ Recovery Systems, Inc.
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2009-06-09
Decision date: 2010-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K091656

K-number listed on FDA's recall record

Z-1111-2017 — SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143Class II·Terminated·Organ Recovery Systems, Inc.·20161214

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091656.

Data sourced from openFDA. This site is unofficial and independent of the FDA.