K951421 is an FDA 510(k) clearance for the GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Global Medical Products, Ltd. (Clearwater, US). The FDA issued a Cleared decision on November 16, 1995, 233 days after receiving the submission on March 28, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K951421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1995 |
| Decision Date | November 16, 1995 |
| Days to Decision | 233 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 |