K973184 is an FDA 510(k) clearance for the PROSTATE SEEDING NEEDLE. This device is classified as a System, Applicator, Radionuclide, Manual (Class I - General Controls, product code IWJ).
Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 21, 1997, 88 days after receiving the submission on August 25, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5650.
| 510(k) Number | K973184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1997 |
| Decision Date | November 21, 1997 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IWJ — System, Applicator, Radionuclide, Manual |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.5650 |