Cleared Traditional

BRACHYSCIENCES STRANDPORT

K062214 · Worldwide Medical Technologies, LLC · Radiology
Mar 2007
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K062214 is an FDA 510(k) clearance for the BRACHYSCIENCES STRANDPORT, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Worldwide Medical Technologies, LLC (Oxford, US). The FDA issued a Cleared decision on March 1, 2007, 212 days after receiving the submission on August 1, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number K062214 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2006
Decision Date March 01, 2007
Days to Decision 212 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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

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