The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Encor Mri Introducer Set, Encor Probe Introducer.
| Device ID | K161805 |
| 510k Number | K161805 |
| Device Name: | EnCor MRI Introducer Set, EnCor Probe Introducer |
| Classification | Instrument, Biopsy |
| Applicant | SENORX, INC. 1625 WEST 3RD STREET Tempe, AZ 85281 |
| Contact | Sarah Mccartney |
| Correspondent | Sarah Mccartney SENORX, INC. 1625 WEST 3RD STREET Tempe, AZ 85281 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-01 |
| Decision Date | 2016-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741086236 | K161805 | 000 |
| 00801741086229 | K161805 | 000 |
| 10801741086196 | K161805 | 000 |
| 10801741086189 | K161805 | 000 |