Select Seed I-125

FDA 510(k) K002429 · Nucletron Corp.

Substantially Equivalent

510(k) numberK002429

Submission

Device name
Select Seed I-125
Applicant
Nucletron Corp.
Columbia, MD, US
Received
August 8, 2000
Decision date
February 2, 2001
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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Questions and answers

When was Select Seed I-125 cleared by the FDA?

Select Seed I-125 (K002429) received a 510(k) decision of Substantially Equivalent on February 2, 2001, 178 days after the submission was received.

What is the product code of K002429?

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