Cleared Traditional

SELECT SEED I-125

K002429 · Nucletron Corp. · Radiology
Feb 2001
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K002429 is an FDA 510(k) clearance for the SELECT SEED I-125, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on February 2, 2001, 178 days after receiving the submission on August 8, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number K002429 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2000
Decision Date February 02, 2001
Days to Decision 178 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KXK — Source, Brachytherapy, Radionuclide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5730

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