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EnCor Breast Biopsy Probe with Rinse Tube

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210654

by Senorx, Inc.

Identifiers

510(k) Number
K210654 FDA 510(k)
FDA Product Code
KNW 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 Breast Biopsy Probe with Rinse Tube is a biopsy instrument classified under Instrument, Biopsy (Class II – Special Controls). It is designed to acquire breast tissue samples for diagnostic evaluation of abnormalities, enabling partial or complete removal of the targeted lesion. The device incorporates a rinse tube to flush collected tissue samples with saline during the procedure, facilitating clearer histologic examination. Its primary function is to assist in the precise acquisition and processing of breast tissue for pathological assessment.

This device is intended for use in clinical settings where breast biopsy procedures are performed, typically under imaging guidance such as ultrasound or mammography. It is supplied as a single-use instrument, as indicated by its regulatory submission. The probe is not intended for MRI use and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality. The FDA granted 510(k) clearance for this device under the product code KNW, with the submission reviewed by the Special Controls (SU) advisory committee.

Frequently asked questions

What is the EnCor Breast Biopsy Probe with Rinse Tube used for?

This device is designed to acquire breast tissue samples for diagnostic evaluation of abnormalities, such as lesions. The integrated rinse tube flushes collected tissue with saline during the procedure, which helps ensure clearer histologic examination. It is intended for use in clinical settings where breast biopsies are performed, typically under imaging guidance like ultrasound or mammography.

Is the EnCor Breast Biopsy Probe with Rinse Tube single-use or reusable?

The EnCor Breast Biopsy Probe with Rinse Tube is supplied as a single-use instrument. This classification aligns with its regulatory submission and manufacturer guidelines to maintain sterility and functionality for one procedure only.

Can this probe be used with MRI imaging?

No, the EnCor Breast Biopsy Probe with Rinse Tube is explicitly not intended for MRI use. It is designed for procedures guided by ultrasound or mammography only.

How should the EnCor Breast Biopsy Probe with Rinse Tube be stored?

The probe must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage conditions are critical to ensure the device remains effective for its intended single-use application.

What regulatory pathway was followed for this device?

The EnCor Breast Biopsy Probe with Rinse Tube received FDA 510(k) clearance under product code KNW. The submission was reviewed by the Special Controls (SU) advisory committee, specifically the Gastroenterology, Urology (GU) panel, and was determined to be substantially equivalent to a predicate device.

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 Breast Biopsy Probe with Rinse Tube (K210654) — FDA 510(k ..., K210654 FDA 510(k) - EnCor Breast Biopsy Probe with Rinse Tube, EnCor Enspire™ Breast Biopsy System - BD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Senorx, Inc.

Sources (1)

  • FDA 510(k) K210654 24 fields · synced Oct 1, 2026