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FDA 510(k)

CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS

K-Number: K132996 · 2013-12-17

ApplicantIsoray, Inc.
Decision Date2013-12-17
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS is the device name listed in this FDA 510(k) record. The listed applicant is Isoray, Inc.. It received FDA 510(k) clearance on 2013-12-17 under 510(k) number K132996. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS?

CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS is a medical device that received FDA 510(k) clearance on 2013-12-17. The listed applicant is Isoray, Inc.. The 510(k) number is K132996.

When did CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS receive FDA 510(k) clearance?

CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS received FDA 510(k) clearance on 2013-12-17, under 510(k) number K132996.

Who is the listed applicant for CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS?

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

What is the FDA product code for CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS?

The FDA product code for CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS is KXK.

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.

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Other records listing Isoray, 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.

K062384CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGEK030162LAWRENCE CSERION, MODEL CS-1

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

Official Source

View on FDA Database →

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

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