K071550 is an FDA 510(k) clearance for the PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Cp Medical (Buford, US). The FDA issued a Cleared decision on July 18, 2007, 42 days after receiving the submission on June 6, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K071550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2007 |
| Decision Date | July 18, 2007 |
| Days to Decision | 42 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 |