Cleared Traditional

K121113 - BIOPSY SCIENCES

K121113 is an FDA 510(k) clearance for BIOPSY SCIENCES, manufactured by Biopsy Sciences, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K121113 · Biopsy Sciences, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2012
Decision
91d
Days
Class 2
Risk

K121113 is an FDA 510(k) clearance for the BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY 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 July 12, 2012 after a review of 91 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biopsy Sciences, LLC devices

FDA 510(k) Submission Details - K121113

510(k) Number K121113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2012
Decision Date July 12, 2012
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 65
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K121113.
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K090547 · C.R. Bard, Inc. · Mar 2009
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
K081085 · Senorx, Inc. · Aug 2008