Cleared Traditional

FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)

K132889 · Nucletron B.V. · Radiology

Feb 2014

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K132889 is an FDA 510(k) clearance for the FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM), a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on February 26, 2014, 163 days after receiving the submission on September 16, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K132889 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2013
Decision Date	February 26, 2014
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF