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FDA 510(k)

EnCor MRI Introducer Set, EnCor Probe Introducer

K-Number: K161805 · 2016-07-19

ApplicantSenorx, Inc.
Decision Date2016-07-19
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EnCor MRI Introducer Set, EnCor Probe Introducer is a medical device manufactured by Senorx, Inc.. It received FDA 510(k) clearance on 2016-07-19 under approval number K161805. 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 MRI Introducer Set, EnCor Probe Introducer?

EnCor MRI Introducer Set, EnCor Probe Introducer is a medical device that received FDA 510(k) clearance on 2016-07-19. It is manufactured by Senorx, Inc.. The 510(k) number is K161805.

When was EnCor MRI Introducer Set, EnCor Probe Introducer approved by the FDA?

EnCor MRI Introducer Set, EnCor Probe Introducer received FDA 510(k) clearance on 2016-07-19, under approval number K161805.

What company makes EnCor MRI Introducer Set, EnCor Probe Introducer?

EnCor MRI Introducer Set, EnCor Probe Introducer is manufactured by Senorx, Inc..

What is the FDA product code for EnCor MRI Introducer Set, EnCor Probe Introducer?

The FDA product code for EnCor MRI Introducer Set, EnCor Probe Introducer is KNW.

Other Devices by Senorx, Inc.

K210654EnCor Breast Biopsy Probe with Rinse Tube 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)

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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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