K233220 is an FDA 510(k) clearance for the EnCor Enspire™Breast Biopsy System (E4115, E4230). 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 October 27, 2023, 29 days after receiving the submission on September 28, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K233220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | October 27, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |