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FDA 510(k)

SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM

K-Number: K072541 · 2007-09-25

ApplicantSenorx, Inc.
Decision Date2007-09-25
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2007-09-25 under 510(k) number K072541. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM?

SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-25. The listed applicant is Senorx, Inc.. The 510(k) number is K072541.

When did SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM receive FDA 510(k) clearance?

SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM received FDA 510(k) clearance on 2007-09-25, under 510(k) number K072541.

Who is the listed applicant for SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM?

The FDA 510(k) record lists Senorx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM?

The FDA product code for SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM is ITX.

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Other records listing Senorx, Inc. as applicant

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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)K210654EnCor Breast Biopsy Probe with Rinse TubeK161805EnCor MRI Introducer Set, EnCor Probe IntroducerK131654STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERK093512ENCOR BREAST BIOPSY SYSTEMK092323CONTURA CAVITY MAINTENANCE CATHETER

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Related Devices (Code: ITX)

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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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