`Bi I-125 Brachytheraphy Seed, Model 125SL & 125SH

FDA 510(k) K984446 · Urocor, Inc.

Substantially Equivalent

510(k) numberK984446

Submission

Device name
`Bi I-125 Brachytheraphy Seed, Model 125SL & 125SH
Applicant
Urocor, Inc.
Oklahoma City, OK, US
Received
December 14, 1998
Decision date
April 16, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

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K223465RadianceTx Radionuclide Brachytherapy SourceKXK · Traditional Radiance Therapeutics, Inc.01/11/2023SE
K221539GammaTileKXK · Traditional Gt Medical Technologies11/09/2022SE
K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesKXK · Traditional Isoray Medical, Inc.12/31/2020SE
K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special Lv Liberty Vision Corporation05/29/2020SE
K190839GammaTileKXK · Traditional Gt Medical Technologies01/23/2020SE
K191324CivaDermKXK · Traditional Civatech Oncology, Inc.09/20/2019SE
K190296GammaTileKXK · Special Gt Medical Technologies03/13/2019SE
K180515GammaTileKXK · Traditional Isoray Medical, Inc.07/06/2018SE

Questions and answers

When was `Bi I-125 Brachytheraphy Seed, Model 125SL & 125SH cleared by the FDA?

`Bi I-125 Brachytheraphy Seed, Model 125SL & 125SH (K984446) received a 510(k) decision of Substantially Equivalent on April 16, 1999, 123 days after the submission was received.

What is the product code of K984446?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.