Cleared Special

K131654 - STARCHMARK BREAST TISSUE MARKER (FDA 510(k) Clearance)

Also includes:

STARCHMARK ULTRACOR BREAST TISSUE MARKER

K131654 · Senorx, Inc. · General & Plastic Surgery device

Jun 2013

Decision

21d

Days

Class 2

Risk

K131654 is an FDA 510(k) clearance for the STARCHMARK BREAST TISSUE MARKER. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).

Submitted by Senorx, Inc. (Tempe, US). The FDA issued a Cleared decision on June 27, 2013, 21 days after receiving the submission on June 6, 2013.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number	K131654 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 06, 2013
Decision Date	June 27, 2013
Days to Decision	21 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF