RADIONUCLIDE BRACHYTHERAPY SOURCE— 510(k) K093663

Name: FDA 510(k) clearance K093663
Creator: U.S. Food and Drug Administration
Published: 2009-12-23

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K093663 for RADIONUCLIDE BRACHYTHERAPY SOURCE, Substantially Equivalent on 2009-12-23. Applicant: C.R. Bard, Inc.. Device class: 2.

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2009-11-25
Decision date: 2009-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Covington, GA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K093663

K-number listed on FDA's recall record

Z-1702-2018 — BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons.Class II·Terminated·Bard Brachytherapy, Inc.·20180410

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093663.

Data sourced from openFDA. This site is unofficial and independent of the FDA.