Cleared Traditional

K152510 - UltraCor Twirl Breast Tissue Marker

K152510 is an FDA 510(k) clearance for UltraCor Twirl Breast Tissue Marker, manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K152510 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
254d
Days
Class 2
Risk

K152510 is an FDA 510(k) clearance for the UltraCor Twirl Breast Tissue Marker. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on May 13, 2016 after a review of 254 days - an extended review 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: 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 Bard Peripheral Vascular, Inc. devices

FDA 510(k) Submission Details - K152510

510(k) Number K152510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2015
Decision Date May 13, 2016
Days to Decision 254 days
Submission Type Traditional
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
139d slower than avg
Panel avg: 115d · This submission: 254d
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 72
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K152510.
UltraCor Twirl Breast Tissue Marker
K180061 · Bard Peripheral Vascular, Inc. · Mar 2018
Magseed Magnetic Marker Systtem
K173587 · Endomagnetics Ltd., · Feb 2018
HydroMARK Breast Biopsy Site Markers
K170803 · Devicor Medical Products, Inc. · Jun 2017
HydroMARK Breast Biopsy Site Marker
K161021 · Devicor Medical Products, Inc. · May 2016
Beacon Fine Needle Fiducial System
K152586 · Covidien, LLC · Dec 2015
CAREFUSION GOLD TISSUE MARKER
K141722 · Care Fusion · Jan 2015