Cleared Special

K152070 - BioZorb LP Marker

K152070 is an FDA 510(k) clearance for BioZorb LP Marker, manufactured by Focal Therapeutics. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 30-day FDA review.

K152070 · Focal Therapeutics · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
30d
Days
Class 2
Risk

K152070 is an FDA 510(k) clearance for the BioZorb LP Marker. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Focal Therapeutics (Portola Valley, US). The FDA issued a Cleared decision on August 26, 2015 after a review of 30 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 Focal Therapeutics devices

FDA 510(k) Submission Details - K152070

510(k) Number K152070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2015
Decision Date August 26, 2015
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 101
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K152070.
HydroMARK Breast Biopsy Site Marker
K161021 · Devicor Medical Products, Inc. · May 2016
Beacon Fine Needle Fiducial System
K152586 · Covidien, LLC · Dec 2015
Beacon Tissue Marker (SE)
K153189 · Scion Medical Technologies, LLC · Dec 2015
TraceIT Tissue Marker - 3mL
K151998 · Augmenix, Inc. · Aug 2015
BioZorb Marker
K143484 · Focal Therapeutics · Jun 2015
BREAST-MED TISSUE MARKER
K133697 · Breast-Med, Inc. · Apr 2015