EnCor EnspireBreast Biopsy System - EnCor™ Breast Biopsy Driver (DRENCOR)
FDA 510(k)Class II (US FDA 510(k))
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)
The EnCor Enspire Breast Biopsy System is a device indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to acquire breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The system includes various models of biopsy drivers and probes, including MRI-compatible versions. The device is supplied as a single-use system and requires appropriate storage conditions. The device has received FDA 510(k) clearance with the product code KNW.
Frequently asked questions
What is the EnCor Enspire Breast Biopsy System used for?
The EnCor Enspire Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities, acquiring tissue for histologic examination with partial or complete removal of the imaged abnormality.
What components are included in the EnCor Enspire Breast Biopsy System?
The system includes various models of biopsy drivers (DRENCOR, DRENCORMR) and probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV, ECPMR017G, ECPMR0110G, ECPMR0110GBT), including MRI-compatible versions.
Is the EnCor Enspire Breast Biopsy System single-use or reusable?
The EnCor Enspire Breast Biopsy System is supplied as a single-use system and requires appropriate storage conditions to maintain its integrity and functionality.
What regulatory status does the EnCor Enspire Breast Biopsy System have?
The device has received FDA 510(k) clearance with the product code KNW, which means it has been determined to be substantially equivalent to predicate devices already on the market.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EnCor Enspire™ Breast Biopsy System - BD, EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy ..., PDF EnCor Enspire Breast Biopsy System - BD, K233220 FDA 510(k) - EnCor EnspireBreast Biopsy System (E4115
Authorization Coverage (1 country)
Regulatory Authorizations
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 Oct 6, 2026