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FDA 510(k)

BRACHYTHERAPY STRAND DEVICE

K-Number: K040339 · 2004-04-08

ApplicantBebig Isotopen-Und Medizintechnik GmbH
Decision Date2004-04-08
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRACHYTHERAPY STRAND DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Bebig Isotopen-Und Medizintechnik GmbH. It received FDA 510(k) clearance on 2004-04-08 under 510(k) number K040339. 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 BRACHYTHERAPY STRAND DEVICE?

BRACHYTHERAPY STRAND DEVICE is a medical device that received FDA 510(k) clearance on 2004-04-08. The listed applicant is Bebig Isotopen-Und Medizintechnik GmbH. The 510(k) number is K040339.

When did BRACHYTHERAPY STRAND DEVICE receive FDA 510(k) clearance?

BRACHYTHERAPY STRAND DEVICE received FDA 510(k) clearance on 2004-04-08, under 510(k) number K040339.

Who is the listed applicant for BRACHYTHERAPY STRAND DEVICE?

The FDA 510(k) record lists Bebig Isotopen-Und Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRACHYTHERAPY STRAND DEVICE?

The FDA product code for BRACHYTHERAPY STRAND DEVICE is KXK.

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Other records listing Bebig Isotopen-Und Medizintechnik GmbH 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.

K033781BEBIG ISOSEED I-125K021343ISOSEEDS I-125

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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