The following data is part of a premarket notification filed by Covidien Llc (formerly Beacon Endoscopic Corp) with the FDA for Sharkcore Fine Needle Biopsy System.
| Device ID | K141894 |
| 510k Number | K141894 |
| Device Name: | SHARKCORE FINE NEEDLE BIOPSY SYSTEM |
| Classification | Biopsy Needle |
| Applicant | COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) 2000 COMMONWEALTH AVE. SUITE 110 Auburndale, MA 02466 -2008 |
| Contact | Saket Bhatt |
| Correspondent | Saket Bhatt COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) 2000 COMMONWEALTH AVE. SUITE 110 Auburndale, MA 02466 -2008 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2014-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855208005131 | K141894 | 000 |
| 00855208005124 | K141894 | 000 |
| 00855208005117 | K141894 | 000 |
| 00855208005100 | K141894 | 000 |
| 00855208005094 | K141894 | 000 |
| 00855208005087 | K141894 | 000 |