Cleared Special

K090501 - BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1

K090501 is an FDA 510(k) clearance for BIOPSY SCIENCES HYDROMARK BREAST BIOPSY..., 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 8-day FDA review.

K090501 · Biopsy Sciences, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
8d
Days
Class 2
Risk

K090501 is an FDA 510(k) clearance for the BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 40.... 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 5, 2009 after a review of 8 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 - K090501

510(k) Number K090501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date March 05, 2009
Days to Decision 8 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
107d faster than avg
Panel avg: 115d · This submission: 8d
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 K090501.
TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
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K090547 · C.R. Bard, Inc. · Mar 2009
BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
K083006 · Biopsy Sciences, LLC · Feb 2009
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
K082278 · Ethicon Endo-Sugery, LLC · Dec 2008
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
K081085 · Senorx, Inc. · Aug 2008