K874585 is an FDA 510(k) clearance for the ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE. This device is classified as a Needle, Biopsy, Cardiovascular (Class I - General Controls, product code DWO).
Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on December 2, 1987, 23 days after receiving the submission on November 9, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K874585 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1987 |
| Decision Date | December 02, 1987 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | DWO — Needle, Biopsy, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |