Cleared Special

TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS

K080871 · Nucletron Corporation · Radiology
Apr 2008
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K080871 is an FDA 510(k) clearance for the TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on April 29, 2008, 29 days after receiving the submission on March 31, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K080871 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2008
Decision Date April 29, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

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