Cleared Traditional

K180061 - UltraCor Twirl Breast Tissue Marker

K180061 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 60-day FDA review.

K180061 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
60d
Days
Class 2
Risk

K180061 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 March 9, 2018 after a review of 60 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 Bard Peripheral Vascular, Inc. devices

FDA 510(k) Submission Details - K180061

510(k) Number K180061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2018
Decision Date March 09, 2018
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
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 K180061.
EchoMark, EchoMark LP
K180621 · Sonavex, Inc. · Jun 2018
SmartClip Soft Tissue Marker
K180640 · Elucent Medical, Inc. · Jun 2018
Tumark Vision
K180443 · Somatex Medical Technologies GmbH · Mar 2018
Magseed Magnetic Marker Systtem
K173587 · Endomagnetics Ltd., · Feb 2018
HydroMARK Breast Biopsy Site Markers
K170803 · Devicor Medical Products, Inc. · Jun 2017
UltraCor Twirl Breast Tissue Marker
K152510 · Bard Peripheral Vascular, Inc. · May 2016