Cleared Traditional

K243642 - UltraCor™ Twirl™ Breast Tissue Marker

K243642 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 118-day FDA review.

K243642 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
118d
Days
Class 2
Risk

K243642 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 24, 2025 after a review of 118 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 Bard Peripheral Vascular, Inc. devices

FDA 510(k) Submission Details - K243642

510(k) Number K243642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2024
Decision Date March 24, 2025
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
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 92
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K243642.
SCOUT MD Surgical Guidance System
K252892 · Merit Medical Systems, Inc. · Dec 2025
VizMark Preloaded Tissue Marker Device (VM-0001)
K251989 · Breast-Med, Inc. · Dec 2025
MammoSTAR Biopsy Site Identifier
K251748 · Carbon Medical Technologies, Inc. · Jul 2025
SmartClip Secure Soft Tissue Marker
K233639 · Elucent Medical, Inc. · Dec 2024
Trilogy Tissue Marker
K240429 · Inrad, Inc. · Nov 2024
MOLLI 2 System
K234149 · Molli Surgical, Inc. · Sep 2024