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FDA 510(k)

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

K-Number: K091656 · 2010-03-11

ApplicantOrgan Recovery Systems, Inc.
Decision Date2010-03-11
Product CodeKDL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L is the device name listed in this FDA 510(k) record. The listed applicant is Organ Recovery Systems, Inc.. It received FDA 510(k) clearance on 2010-03-11 under 510(k) number K091656. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L?

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is Organ Recovery Systems, Inc.. The 510(k) number is K091656.

When did SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L receive FDA 510(k) clearance?

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L received FDA 510(k) clearance on 2010-03-11, under 510(k) number K091656.

Who is the listed applicant for SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L?

The FDA 510(k) record lists Organ Recovery Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L?

The FDA product code for SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L is KDL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Organ Recovery Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021362LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)K022391MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIIONK013575KPS-I, THE KIDNEY PERFUSION SOLUTION

Related Devices (Code: KDL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241239OrganProtex HTK SolutionBridge TO Life, Ltd.K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges LopezK221387BEL-GEN Cold Storage SolutionInstitut Georges LopezK211842Servator M SALF SolutionS.A.L.F. SpaK192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbHK170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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