K150891 is an FDA 510(k) clearance for the BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Covidien, LLC( Formerly Beacon Endoscopic Corp.) (Mansfield, US). The FDA issued a Cleared decision on May 1, 2015, 29 days after receiving the submission on April 2, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K150891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2015 |
| Decision Date | May 01, 2015 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FCG — Biopsy Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |