K871467 is an FDA 510(k) clearance for the BIOPSY NEEDLE GUIDE KIT, STERILE. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Amedic USA (Phoenix, US). The FDA issued a Cleared decision on August 21, 1987, 129 days after receiving the submission on April 14, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K871467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1987 |
| Decision Date | August 21, 1987 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FCG — Biopsy Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |