Cleared Abbreviated

BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS

K103449 · Riverpoint Medical · Radiology
Feb 2011
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K103449 is an FDA 510(k) clearance for the BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on February 25, 2011, 94 days after receiving the submission on November 23, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number K103449 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2010
Decision Date February 25, 2011
Days to Decision 94 days
Submission Type Abbreviated
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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