Cleared Traditional

K031938 - GEL MARK III BIOPSY SITE MARKER

K031938 is the FDA 510(k) clearance for GEL MARK III BIOPSY SITE MARKER by Senorx, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K031938 · Senorx, Inc. · General & Plastic Surgery device
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Sep 2003
Decision
74d
Days
Class 2
Risk

K031938 is an FDA 510(k) clearance for the GEL MARK III BIOPSY SITE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 74 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Senorx, Inc. devices

Submission Details

510(k) Number K031938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date September 05, 2003
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 58
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K031938.
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K051421 · Medical Device Technologies, Inc. · Aug 2005
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
K040990 · Walter Lorenz Surgical, Inc. · May 2004
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
K033447 · Mri Devices Corp. · Jan 2004
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
K020276 · Ethicon Endo-Surgery, Inc. · Apr 2002
SELF-DRILLING RADIOGRAPHIC MARKER
K014148 · Walter Lorenz Surgical, Inc. · Jan 2002
MICROMARK II TISSUE MARKER,MODEL C1535
K013413 · Ethicon Endo-Surgery, Inc. · Dec 2001