K885149 is an FDA 510(k) clearance for the NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE. This device is classified as a Needle, Biopsy, Cardiovascular (Class I - General Controls, product code DWO).
Submitted by Hart Enterprises, Inc. (Wyoming, US). The FDA issued a Cleared decision on January 26, 1989, 42 days after receiving the submission on December 15, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K885149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1988 |
| Decision Date | January 26, 1989 |
| Days to Decision | 42 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 |