Cleared Special

K130537 - BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER

K130537 is an FDA 510(k) clearance for BIOPSY SCIENCES LLC HYDROMARK BREAST BI..., manufactured by Biopsy Sciences, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 28-day FDA review.

K130537 · Biopsy Sciences, LLC · General & Plastic Surgery device
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Mar 2013
Decision
28d
Days
Class 2
Risk

K130537 is an FDA 510(k) clearance for the BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Biopsy Sciences, LLC (Yorba Linda, US). The FDA issued a Cleared decision on March 29, 2013 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biopsy Sciences, LLC devices

FDA 510(k) Submission Details - K130537

510(k) Number K130537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2013
Decision Date March 29, 2013
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

NEU Device Classification - Class 2, Special Controls

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEU Marker, Radiographic, Implantable

All 107
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K130537.
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BEACON TISSUE MARKER
K130763 · Scion Medical Technologies, LLC · May 2013
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
K121964 · Augmenix, Inc. · Jan 2013
SENOMARK ULTRA BREAST TISSUE MARKER
K123911 · C.R. Bard, Inc. · Jan 2013
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
K121113 · Biopsy Sciences, LLC · Jul 2012