K871503 is an FDA 510(k) clearance for the BIOPSY NEEDLE GUIDE KIT, STERILE. This device is classified as a Guide, Surgical, Instrument (Class I - General Controls, product code FZX).
Submitted by Amedic USA (Phoenix, US). The FDA issued a Cleared decision on July 10, 1987, 84 days after receiving the submission on April 17, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K871503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1987 |
| Decision Date | July 10, 1987 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZX — Guide, Surgical, Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |