K954596 is an FDA 510(k) clearance for the PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Promedical , Ltd. (Wyckoff, US). The FDA issued a Cleared decision on October 7, 1995, 4 days after receiving the submission on October 3, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K954596 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 1995 |
| Decision Date | October 07, 1995 |
| Days to Decision | 4 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 |