K945124 is an FDA 510(k) clearance for the BREAST LESION LOCALIZATION NEEDLE, a Guide, Needle, Surgical (Class I — General Controls, product code GDF), submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 22, 1994, 34 days after receiving the submission on October 19, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K945124 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 19, 1994 |
| Decision Date | November 22, 1994 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDF — Guide, Needle, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |