K850726 is an FDA 510(k) clearance for the WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD. This device is classified as a Source, Wire, Iridium, Radioactive (Class II - Special Controls, product code IWA).
Submitted by Syncor Intl. Corp. (Sylmar, US). The FDA issued a Cleared decision on March 26, 1985, 32 days after receiving the submission on February 22, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K850726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1985 |
| Decision Date | March 26, 1985 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWA — Source, Wire, Iridium, Radioactive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |