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EnCor Enspire™Breast Biopsy System (E4115, E4230) +4 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K233220
by Senorx, Inc.
Identifiers
- 510(k) Number
- K233220 FDA 510(k)
- FDA Product Code
- KNW FDA 510(k)
- Models / Variants
- EnCor™ Breast Biopsy Driver (DRENCOR) FDA 510(k)EnCor™ MRI Breast Biopsy Driver (DRENCORMR) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1075 FDA 510(k)
- Regulation Number
- 876.1075 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EnCor Enspire™Breast Biopsy System (E4115, E4230) +4 more models by Senorx, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 5 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233220 | Class II | Active |
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Manufacturer
- Manufacturer
- Senorx, Inc.
Sources (1)
- FDA 510(k) K233220 24 fields · synced Jun 18, 2026