K010821 is an FDA 510(k) clearance for the ECHOSEED/IODINE-125 SEEDS, MODEL 6733. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging (Arlington Heights, US). The FDA issued a Cleared decision on April 11, 2001, 23 days after receiving the submission on March 19, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K010821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2001 |
| Decision Date | April 11, 2001 |
| Days to Decision | 23 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 |