K161805 is an FDA 510(k) clearance for the EnCor MRI Introducer Set, EnCor Probe Introducer. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Senorx, Inc. (Tempe, US). The FDA issued a Cleared decision on July 19, 2016, 18 days after receiving the submission on July 1, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K161805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2016 |
| Decision Date | July 19, 2016 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |