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FDA 510(k)

POIINT OF CARE STRANDING SYSTEM, MODE 1004-00

K-Number: K072296 · 2007-09-26

ApplicantTheragenics Corp.
Decision Date2007-09-26
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 is the device name listed in this FDA 510(k) record. The listed applicant is Theragenics Corp.. It received FDA 510(k) clearance on 2007-09-26 under 510(k) number K072296. 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 POIINT OF CARE STRANDING SYSTEM, MODE 1004-00?

POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 is a medical device that received FDA 510(k) clearance on 2007-09-26. The listed applicant is Theragenics Corp.. The 510(k) number is K072296.

When did POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 receive FDA 510(k) clearance?

POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 received FDA 510(k) clearance on 2007-09-26, under 510(k) number K072296.

Who is the listed applicant for POIINT OF CARE STRANDING SYSTEM, MODE 1004-00?

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

What is the FDA product code for POIINT OF CARE STRANDING SYSTEM, MODE 1004-00?

The FDA product code for POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 is KXK.

Related Clinical Trials

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Other records listing Theragenics Corp. 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.

K103319I-SEEDK043596THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06K010283THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200K874787MODIFIED PALLADIUM SEED MODEL 100

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

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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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