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FDA 510(k)

PROSTEC 125I BRACHYTHERAPY SEEDS

K-Number: K993280 · 2000-03-14

ApplicantProstec, LLC
Decision Date2000-03-14
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROSTEC 125I BRACHYTHERAPY SEEDS is the device name listed in this FDA 510(k) record. The listed applicant is Prostec, LLC. It received FDA 510(k) clearance on 2000-03-14 under 510(k) number K993280. 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 PROSTEC 125I BRACHYTHERAPY SEEDS?

PROSTEC 125I BRACHYTHERAPY SEEDS is a medical device that received FDA 510(k) clearance on 2000-03-14. The listed applicant is Prostec, LLC. The 510(k) number is K993280.

When did PROSTEC 125I BRACHYTHERAPY SEEDS receive FDA 510(k) clearance?

PROSTEC 125I BRACHYTHERAPY SEEDS received FDA 510(k) clearance on 2000-03-14, under 510(k) number K993280.

Who is the listed applicant for PROSTEC 125I BRACHYTHERAPY SEEDS?

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

What is the FDA product code for PROSTEC 125I BRACHYTHERAPY SEEDS?

The FDA product code for PROSTEC 125I BRACHYTHERAPY SEEDS 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 Prostec, LLC 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.

K001366PROSTEC 125I BRANCHYTHERAPY SNAPSEED

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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