K926559 is an FDA 510(k) clearance for the PROACT BIOPSY NEEDLE ENCHANCEMENTS. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Proact, Ltd. (State College, US). The FDA issued a Cleared decision on March 22, 1993, 81 days after receiving the submission on December 31, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K926559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 1992 |
| Decision Date | March 22, 1993 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCG — Biopsy Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |