The following data is part of a premarket notification filed by Covidien Llc with the FDA for Bnx Fine Needle Aspiration System.
| Device ID | K142198 |
| 510k Number | K142198 |
| Device Name: | BNX Fine Needle Aspiration System |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Covidien LLC 2000 Commonwealth Ave Suite 110 Auburndale, MA 02466 |
| Contact | Saket Bhatt |
| Correspondent | Saket Bhatt Covidien LLC 2000 Commonwealth Ave Suite 110 Auburndale, MA 02466 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2014-10-08 |
| Summary: | summary |