K043596 is an FDA 510(k) clearance for the THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Theragenics Corp. (Buford, US). The FDA issued a Cleared decision on January 26, 2005, 28 days after receiving the submission on December 29, 2004.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K043596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2004 |
| Decision Date | January 26, 2005 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KXK — Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |