The following data is part of a premarket notification filed by Covidien Llc( Formerly Beacon Endoscopic Corp.) with the FDA for Bnx Fine Needle Aspiration System And Sharkcore Lg Fine Needle Biopsy System.
| Device ID | K150891 |
| 510k Number | K150891 |
| Device Name: | BNX Fine Needle Aspiration System And SharkCore LG Fine Needle Biopsy System |
| Classification | Biopsy Needle |
| Applicant | Covidien LLC( Formerly Beacon Endoscopic Corp.) 15 Hamshire Street Mansfield, MA 02048 |
| Contact | Saket Bhatt |
| Correspondent | Saket Bhatt Covidien 540 Oakmead Parkway Sunnyvale, CA 94085 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-02 |
| Decision Date | 2015-05-01 |
| Summary: | summary |