K092136 is an FDA 510(k) clearance for the PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Isoray Medical, Inc. (Richland, US). The FDA issued a Cleared decision on August 7, 2009, 23 days after receiving the submission on July 15, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K092136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2009 |
| Decision Date | August 07, 2009 |
| 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 |