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FDA 510(k)

UROMED BRACHYTHERAPHY IODINE-125 SOURCES

K-Number: K982226 · 1999-05-13

ApplicantUromed Corp.
Decision Date1999-05-13
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UROMED BRACHYTHERAPHY IODINE-125 SOURCES is the device name listed in this FDA 510(k) record. The listed applicant is Uromed Corp.. It received FDA 510(k) clearance on 1999-05-13 under 510(k) number K982226. 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 UROMED BRACHYTHERAPHY IODINE-125 SOURCES?

UROMED BRACHYTHERAPHY IODINE-125 SOURCES is a medical device that received FDA 510(k) clearance on 1999-05-13. The listed applicant is Uromed Corp.. The 510(k) number is K982226.

When did UROMED BRACHYTHERAPHY IODINE-125 SOURCES receive FDA 510(k) clearance?

UROMED BRACHYTHERAPHY IODINE-125 SOURCES received FDA 510(k) clearance on 1999-05-13, under 510(k) number K982226.

Who is the listed applicant for UROMED BRACHYTHERAPHY IODINE-125 SOURCES?

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

What is the FDA product code for UROMED BRACHYTHERAPHY IODINE-125 SOURCES?

The FDA product code for UROMED BRACHYTHERAPHY IODINE-125 SOURCES is KXK.

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Other records listing Uromed 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.

K010213MODIFICATION TO CAVERMAP SURGICAL AIDK010098MODIFICATION TO CAVERMAP SURGICAL AIDK000507CAVERMAP SURGICAL AIDK993436CAVERMAP SURGICAL AIDK980717UROMED SLING KITK974600UROMED PATCH

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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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