Seed Link

FDA 510(k) K023073 · Implant Sciences Corp.

Substantially Equivalent

510(k) numberK023073

Submission

Device name
Seed Link
Applicant
Implant Sciences Corp.
Wakefield, MA, US
Received
September 16, 2002
Decision date
April 7, 2003
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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K221539GammaTileKXK · Traditional Gt Medical Technologies11/09/2022SE
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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

More from Isoray Medical, Inc.

510(k)DeviceDecision
K070468Implant Sciences Corp. Model HDR 4454KXK · Special 03/23/2007SE
K042864Implant Sciences Corp, Model HDR-4140KXK · Traditional 01/06/2005SE
K023242I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileKXK · Special 12/04/2002SE
K994317I-Plant, Model 3500KXK · Traditional 03/21/2000SE
K990193Iodine Brachytherapy Seeds, Model 3000KXK · Traditional 05/20/1999SE

Questions and answers

When was Seed Link cleared by the FDA?

Seed Link (K023073) received a 510(k) decision of Substantially Equivalent on April 7, 2003, 203 days after the submission was received.

What is the product code of K023073?

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