The following data is part of a premarket notification filed by Covidien Llc with the FDA for Beacon Eus Access System.
| Device ID | K180037 |
| 510k Number | K180037 |
| Device Name: | Beacon EUS Access System |
| Classification | Biopsy Needle |
| Applicant | Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Contact | Rachel Silva |
| Correspondent | Rachel Silva Covidien Llc 15 Hampshire Street Mansfield, MA 02048 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-05 |
| Decision Date | 2018-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521722583 | K180037 | 000 |
| 10884521663527 | K180037 | 000 |