K072296 is an FDA 510(k) clearance for the POIINT OF CARE STRANDING SYSTEM, MODE 1004-00. 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 September 26, 2007, 40 days after receiving the submission on August 17, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K072296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2007 |
| Decision Date | September 26, 2007 |
| Days to Decision | 40 days |
| Submission Type | Abbreviated |
| 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 |