Cleared Traditional

SMIT SLEEVE

K052228 · Nucletron Corporation · Radiology
Nov 2005
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K052228 is an FDA 510(k) clearance for the SMIT SLEEVE, 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 November 9, 2005, 85 days after receiving the submission on August 16, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K052228 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2005
Decision Date November 09, 2005
Days to Decision 85 days
Submission Type Traditional
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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