Cleared Traditional

K023694 - BIO-MARK RESORBABLE BIOPSY SITE MARKER ...

K023694 is an FDA 510(k) clearance for BIO-MARK RESORBABLE BIOPSY SITE MARKER ..., 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 136-day FDA review.

K023694 · Biopsy Sciences, LLC · General & Plastic Surgery device
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Mar 2003
Decision
136d
Days
Class 2
Risk

K023694 is an FDA 510(k) clearance for the BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT 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 17, 2003 after a review of 136 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 - K023694

510(k) Number K023694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date March 17, 2003
Days to Decision 136 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
21d slower than avg
Panel avg: 115d · This submission: 136d
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 K023694.
GEL MARK IV
K040706 · Senorx, Inc. · Apr 2004
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
K033447 · Mri Devices Corp. · Jan 2004
GEL MARK III BIOPSY SITE MARKER
K031938 · Senorx, Inc. · Sep 2003
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