FDA 510(k)

STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER

K-Number: K131654 · 2013-06-27

Decision Date2013-06-27

Product CodeNEU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2013-06-27 under 510(k) number K131654. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER?

STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER is a medical device that received FDA 510(k) clearance on 2013-06-27. The listed applicant is Senorx, Inc.. The 510(k) number is K131654.

When did STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER receive FDA 510(k) clearance?

STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER received FDA 510(k) clearance on 2013-06-27, under 510(k) number K131654.

Who is the listed applicant for STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER?

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 STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER?

The FDA product code for STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER is NEU.

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Related Devices (Code: NEU)

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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.