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FDA 510(k)

EnCor Breast Biopsy Probe with Rinse Tube

K-Number: K210654 · 2021-03-31

ApplicantSenorx, Inc.
Decision Date2021-03-31
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EnCor Breast Biopsy Probe with Rinse Tube is a medical device manufactured by Senorx, Inc.. It received FDA 510(k) clearance on 2021-03-31 under approval number K210654. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnCor Breast Biopsy Probe with Rinse Tube?

EnCor Breast Biopsy Probe with Rinse Tube is a medical device that received FDA 510(k) clearance on 2021-03-31. It is manufactured by Senorx, Inc.. The 510(k) number is K210654.

When was EnCor Breast Biopsy Probe with Rinse Tube approved by the FDA?

EnCor Breast Biopsy Probe with Rinse Tube received FDA 510(k) clearance on 2021-03-31, under approval number K210654.

What company makes EnCor Breast Biopsy Probe with Rinse Tube?

EnCor Breast Biopsy Probe with Rinse Tube is manufactured by Senorx, Inc..

What is the FDA product code for EnCor Breast Biopsy Probe with Rinse Tube?

The FDA product code for EnCor Breast Biopsy Probe with Rinse Tube is KNW.

Related Clinical Trials

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Other Devices by Senorx, Inc.

K161805EnCor MRI Introducer Set, EnCor Probe Introducer K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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