Cleared Special

K003270 - PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
(FDA 510(k) Clearance)

K003270 · Nucletron Corp. · Radiology

Dec 2000

Decision

65d

Days

Class 2

Risk

K003270 is an FDA 510(k) clearance for the PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Nucletron Corp. (Columbia, US). The FDA issued a Cleared decision on December 22, 2000, 65 days after receiving the submission on October 18, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number	K003270 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2000
Decision Date	December 22, 2000
Days to Decision	65 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF